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Medical Device CROs for Regulatory Affairs Management Market, 2019-2030

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    November 2019

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Overview

Presently, several medical devices are being investigated in clinical trials for variety of indications across the globe that are likely to get market approval in near future. In order to facilitate the approval in different geographies, there seems to be enhanced business opportunities for companies offering required services in this domain.

-- Business Development Manager, a Hungary based Mid-sized company

According to the World Bank, more than 50,000 different types of medical devices are currently being used on a daily basis in healthcare facilities across the globe. In 2018, the global medical devices market was estimated to have reached a net worth of approximately USD 450 billion.  It is also worth noting that, since in the same year, the USFDA approved over 130 medical devices. ,   However, a relatively large proportion of developers lack the resources and technical expertise required to handle regulatory filings and effectively manage the processes associated with procuring marketing authorizations from regional regulators. Moreover, keeping up with evolving regulatory guidelines, rising costs of legal advice and increasing effort required for preparing of technical documentation, is difficult for companies with limited finances. In addition, establishing reimbursement strategies for medium to high-risk devices is also a complicated process and innovator companies usually do not have the expertise to deal with payers and insurance providers. According to a recent report, 68% of medical device companies reports prepared and submitted by in-house players are either rejected or were reported to have multiple major gaps in their clinical evaluation report (CER) and supporting evidences by the notified bodies.  In fact. in a survey published in the 2016 edition of Global Medical Device Supply Chain, regulatory requirements were highlighted among the primary areas of concern within the medical device value chain. Furthermore, the implementation of highly stringent regulatory guidelines, specifically for devices posing medium to high risk to consumers, render them subject to rigorous quality assessments. 
The aforementioned challenges have led many medical device developers, especially the smaller players and certain established companies as well, to outsource parts of their regulatory operations to capable contract research organizations (CROs). Generally, CROs are known to offer a number of benefits, which include cost benefits, reductions in time-to-market and, in this specific case, an in-depth and up-to date regulatory support. Given that the global demand for medical devices is increasing at a substantial pace, the opportunity for CROs with expertise in regulatory affairs management is also on the rise. In the foreseen future, the growing complexity of regulatory processes across various developing and developed geographies is likely to prompt more developers to outsource various aspects of their dealings with regulatory authorities. Moreover, in order to cope up with latest changes in medical device-related regulations, several legacy CROs are re-evaluating their operational models and business strategies. Owing to the anticipated rise in demand for such services, the contract regulatory services domain is likely to witness the entry of a number of new players in the foreseen future.

Scope of the Report

The ‘Contract Regulatory Affairs Management Market for Medical Devices, 2019-2030’ report features a detailed study on the current landscape of contract service providers focused on regulatory affairs management for medical devices. The study features an in-depth analysis, highlighting the capabilities of the various CROs engaged in this domain, across different regions of the globe. Amongst other elements, the report includes:

  • A detailed review of the current market landscape of the medical devices regulatory affairs outsourcing market, featuring a list of over 400 CROs engaged in this domain, and detailed analysis based on a number of relevant parameters, such as year of establishment, size of employee base, geographical location, device class (class I, class II, and class III), type and size of clientele (medical device developers, medical device manufacturers, medical device research organizations, and others), types of services offered, ([A] regulatory management services (such as legal representation, notified body selection, project registration and clinical trial application, regulatory writing and publishing, regulatory document submission, product labelling related service, gap-analysis, technical dossier set-up, vigilance & medical device report, risk management-related services), [B] additional services (such as biostatistics, consulting, clinical operations, post-marketing activities, quality assurance, reimbursement, training)), region(s) of operation wherein the company is offering regulatory management services. 
  • A detailed discussion on the need for regulatory review / oversight across different stages of the medical devices supply chain, with emphasis on the optimization of the supply chain using upcoming tools / technologies (such as artificial intelligence, big data analytical, blockchain, internet of things and others).
  • An elaborate discussion on the various guidelines established by major regulatory bodies for medical device approval across North America (the US, Canada and Mexico), Europe (France, Germany, Italy, Spain, the UK and rest of Europe), Asia-Pacific and rest of the world (Australia, Brazil, China, India, Israel, Japan, New Zealand, Singapore, South Africa, South Korea, Taiwan, and Thailand). The report also features an insightful multi-dimensional, heat map analysis, featuring a comparison of the contemporary regulatory and reimbursement scenarios in key geographies across the globe.
  • Elaborate profiles of popular players that specialize in offering end-to-end regulatory services for medical devices across key geographies (North America, Europe and Asia-Pacific). Each profile features a brief overview of the company, including information on company headquarters, year of establishment, number of employees, and therapeutic area expertise, financial information (if available), detailed description of service portfolio, and an informed future outlook.
  • A benchmark analysis, highlighting the key focus areas of very small-sized, small-sized, mid-sized and large companies, comparing their existing capabilities within and beyond their respective peer groups, providing a means for stakeholders to identify ways to gain a competitive edge in the industry.
  • An elaborate discussion on the various outsourcing business models adopted for regulatory affairs management, along with an insightful Harvey ball analysis of key considerations that need to be assessed by industry stakeholders while selecting a CRO partner.
  • An analysis highlighting the key performance indicators used by sponsor companies to evaluate service providers that are active in the domain, based on information gathered via secondary research (for top-ten medical device players) and primary research.
  • A survey analysis featuring inputs solicited from various experts who are directly / indirectly involved in providing regulatory affairs management services to medical device developers. 

One of the key objectives of this report was to evaluate the current opportunity and the future potential of the medical device regulatory affairs outsourcing market over the coming decade. We have provided an informed estimate of the likely evolution of the market in the short to mid-term and long term, for the period 2019-2030. In addition, we have provided the likely distribution of the opportunity across different [A] types of regulatory affair management service offered (legal representation, project registration and clinical trial application, regulatory writing and publishing  and 6+ categories) [B] device class (class I, class II and class III), [C] therapeutic areas (cardiovascular disorders, central nervous system (CNS) disorders, metabolic disorders, oncological disorders, orthopedic disorders, ophthalmic disorders, pain disorders, respiratory disorders, and others), and [D] geographical regions (North America, Europe, Asia-Pacific and rest of the world). To account for the uncertainties associated with the growth of the medical device regulatory affairs outsourcing CRO market and to add robustness to our model, we have provided three forecast scenarios, portraying the conservative, base and optimistic tracks of the market’s evolution.

The opinions and insights presented in the report were also influenced by discussions held with senior stakeholders in the industry. The report features detailed transcripts of interviews held with the following industry stakeholders (in alphabetical order of company name): 

  • Tania Persson, Business Development Manager, A+ Science
  • Alexa Foltin-Mertgen, Business Development Manager, AtoZ-CRO
  • Troy Mccall, Chief Operating Officer, CROMSOURCE
  • Christian Wolflehner, Managing Director, Clinical Trial Specialist, CW Research & Management
  • Antal Solyom, Director, Medical Device Unit, HungaroTrial
  • Nazish Urooj, Senior manager, Medical & Clinical Operations, Metrics Research
  • C Omprakash, Technical Director and Partner, Vyomus Consulting 

All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.
 

Contents

Chapter Outlines

Chapter 2 provides an executive summary of the insights captured in our research. It offers a high-level view on the current state of the medical device regulatory affairs management CROs market and its likely evolution in the short-midterm and long term.

Chapter 3 is a general overview of the various types of CROs that offer services to the medical devices industry. It provides a brief introduction to the concept of CROs, featuring a discussion on the historical evolution of contract research services market in this domain. Further, it elaborates on the need for outsourcing in this domain, along with the various partnership models that have been adopted by CROs and medical device developers. In addition, the chapter highlights key points that developer companies need to consider for selecting a suitable contract research services provider for regulatory management services. It also features a detailed list of regulatory management services offered by contemporary CROs, along with a discussion on the various challenges within the market.

Chapter 4 includes a detailed discussion on the need of regulatory review / oversight across different stages of the medical device supply chain. It also emphasizes on the various factors that are likely to impact the performance of the medical device supply chain, along with strategies that are likely to assist in improving visibility in the supply chain. Subsequently, the chapter provides information on optimization of the supply chain using upcoming tools / technologies (such as artificial intelligence, big data analytical, blockchain, internet of things and others).

Chapter 5 features a discussion on the various guidelines established by major regulatory bodies for medical device approvals across North America (the US, Canada and Mexico), Europe (France, Germany, Italy, Spain, the UK and rest of Europe), Asia-Pacific and rest of the world (Australia, Brazil, China, India, Israel, Japan, New Zealand, Singapore, South Africa, South Korea, Taiwan, and Thailand). The report also features an insightful multi-dimensional heat map analysis, featuring a comparison of the contemporary regulatory and reimbursement scenarios in key geographies across the globe. 

Chapter 6 provides a detailed review of the current market landscape of the medical devices regulatory affairs outsourcing market, featuring a comprehensive list of over 400 CROs engaged in this domain. In addition, it features an in-depth analysis of the market, based on a number of relevant parameters, such as year of establishment, size of employee base, geographical location, device class (class I, class II, and class III), type and size of clientele (medical device developers, medical device manufacturers, medical device research organizations, and others), types of services offered, ([A] regulatory management services (such as legal representation, notified body selection, project registration and clinical trial application, regulatory writing and publishing, regulatory document submission, product labelling related service, gap-analysis, technical dossier set-up, vigilance & medical device report risk management-related services), [B] additional services (such as biostatistics, consulting, clinical operations, post-marketing activities, quality assurance, reimbursement, training), region(s) of operation wherein the company is offering regulatory management services. 

Chapter 7 features detailed profiles of popular players that specialize in offering end-to-end regulatory services for medical devices across key geographies (North America, Europe and Asia-Pacific), featuring a brief overview of the company including information on company headquarters, year of establishment, number of employees, and therapeutic area expertise, financial information (if available), detailed description of service portfolio, and an informed future outlook.

Chapter 8 presents a benchmark analysis of the various players engaged in this domain. It highlights the focus areas of very small-sized, small-sized, mid-sized and large companies in terms of their expertise in medical device services. The analysis allows companies to compare their existing capabilities within and beyond their respective peer groups, providing a means for stakeholders to identify ways to gain a competitive edge in the industry.

Chapter 9 features an elaborate discussion on the various outsourcing business models adopted for regulatory affairs management in this domain, along with an informative Harvey ball analysis of key considerations that need to be assessed by industry stakeholders while selecting a CRO partner.

Chapter 10 features an analysis on the key performance indicators used by sponsor companies to evaluate service providers that are active in this domain, based on information gathered via secondary research (for top-ten medical device players), as well as credible inputs from primary research.

Chapter 11 presents a likely evolution of the market in the short to mid-term and long term (2019-2030). In addition, we have provided the likely distribution of the opportunity across different [A] types of regulatory affair management services offered (legal representation, project registration and clinical trial application, regulatory writing and publishing  and 6+ categories) [B] device class (class I, class II and class III), [C] therapeutic areas (cardiovascular disorders, central nervous system (CNS) disorders, metabolic disorders, oncological disorders, orthopedic disorders, ophthalmic disorders, pain disorders, respiratory disorders, and others), and [D] geographical regions (North America, Europe, Asia-Pacific and rest of the world).

Chapter 12 is a summary of the entire report. It provides the key takeaways and presents our independent opinion of the medical device regulatory affairs outsourcing market, based on the research and analysis described in the previous chapters.

Chapter 13 presents insights from the survey conducted for this study. We invited over 300 stakeholders that provide regulatory affairs management services to medical device developers / manufacturers. The participants, who were primarily CXO level / senior management representatives of their respective companies, helped us develop a deeper understanding on the nature of their services, prevalent trends and associated commercial potential of this domain.

Chapter 14 is a collection of interview transcripts of the discussions held with key stakeholders in this market. In this chapter, we have presented the details of interviews held with (in alphabetical order of company names) Tania Persson (Business Development Manager, A+ Science), Alexa Foltin-Mertgen (Business Development Manager, AtoZ-CRO), Troy Mccall (Chief Operating Officer, CROMSOURCE), Christian Wolflehner (Managing Director, Clinical Trial Specialist, CW Research & Management), Antal Solyom (Director, Medical Device Unit, HungaroTrial), Nazish Urooj (Senior manager, Medical & Clinical Operations, Metrics Research), and C Omprakash (Technical Director and Partner, Vyomus Consulting).

Chapter 15 is an appendix, which provides tabulated data and numbers for all the figures included in the report.

Chapter 16 is an appendix, which provides the list of companies and organizations mentioned in this report.

Table Of Contents

1. PREFACE
1.1. Scope of the Report
1.2. Research Methodology
1.3. Chapter Outlines

2. EXECUTIVE SUMMARY

3. INTRODUCTION
3.1. Chapter Overview
3.2. Contract Research Organizations (CROs)
3.2.1. Evolution of CROs
3.3. Role of CROs in the Medical Device Industry
3.4. Types of Medical Device CROs
3.5. Types of Services Offered by CROs
3.5.1. Types of Regulatory Affairs-Related Services Offered by CROs
3.6. Need for Outsourcing Regulatory Affairs-Related Operations for Medical Devices
3.7. Key Considerations for Selecting a Suitable CRO Partner
3.8. Advantages of Working with CROs
3.9. Risks and Challenges Related to Working with CROs
3.10. Concluding Remarks

4. ROLE OF REGULATORY AFFAIRS IN MEDICAL DEVICE SUPPLY CHAIN
4.1. Chapter Overview
4.2. Overview of Medical Device Supply Chain
4.2.1. Importance of Regulatory Affairs in Medical Device Supply Chain
4.2.1.1. Concept and Feasibility Assessment Stage
4.2.1.2. Preclinical Stage
4.2.1.3. Manufacturing / Production Stage
4.2.1.4. Marketing Stage
4.2.1.5. Post-Marketing Stage
4.3. Factors Affecting the Medical Device Supply Chain
4.4. Key Performance Indicators for Medical Device Supply Chain Management
4.5. Optimization of Regulatory Affairs in the Medical Device Supply Chain
4.5.1. Digitalization of the Medical Device Supply Chain

5. REGULATORY AND REIMBURSEMENT LANDSCAPE FOR MEDICAL DEVICES
5.1. Chapter Overview
5.2. General Regulatory and Reimbursement Guidelines for Medical Devices
5.3. Regulatory and Reimbursement Landscape in North America
5.3.1. The US Scenario
5.3.1.1. Regulatory Authority
5.3.1.2. Review / Approval Process
5.3.1.3. Reimbursement Landscape
5.3.1.3.1. Payer Mix
5.3.1.3.2. Reimbursement Process
5.3.2. The Canadian Scenario
5.3.2.1. Regulatory Authority
5.3.2.2. Review / Approval Process
5.3.2.3. Reimbursement Landscape
5.3.2.3.1. Payer Mix
5.3.2.3.2. Reimbursement Process
5.3.3. The Mexican Scenario
5.3.3.1. Regulatory Authority
5.3.3.2. Review / Approval Process
5.3.3.3. Reimbursement Landscape
5.3.3.3.1. Payer Mix
5.4. Regulatory and Reimbursement Landscape in Europe
5.4.1. Overall Scenario
5.4.1.1. Overall Regulatory Authority
5.4.1.2. Overall Review / Approval Process
5.4.2. The UK Scenario
5.4.2.1. Regulatory Authority
5.4.2.2. Review / Approval Process
5.4.2.3. Reimbursement Landscape
5.4.2.3.1. Payer Mix
5.4.2.3.2. Reimbursement Process
5.4.3. The French Scenario
5.4.3.1. Regulatory Authority
5.4.3.2. Review / Approval Process
5.4.3.3. Reimbursement Landscape
5.4.3.3.1. Payer Mix
5.4.3.3.2. Reimbursement Process
5.4.4. The German Scenario
5.4.4.1. Regulatory Authority
5.4.4.2. Review / Approval Process
5.4.4.3. Reimbursement Landscape
5.4.4.3.1. Payer Mix
5.4.4.3.2. Reimbursement Process
5.4.5. The Italian Scenario
5.4.5.1. Regulatory Authority
5.4.5.2. Review / Approval Process
5.4.5.3. Reimbursement Landscape
5.4.5.3.1. Payer Mix
5.4.5.3.2. Reimbursement Process
5.4.6. The Spanish Scenario
5.4.6.1. Regulatory Authority
5.4.6.2. Review / Approval Process
5.4.6.3. Reimbursement Landscape
5.4.6.3.1. Payer Mix
5.4.6.3.2. Reimbursement Process
5.5. Regulatory and Reimbursement Landscape in Asia-Pacific and Rest of the World
5.5.1. The Australian Scenario
5.5.1.1. Regulatory Authority
5.5.1.2. Review / Approval Process
5.5.1.3. Reimbursement Landscape
5.5.1.3.1. Payer Mix
5.5.1.3.2. Reimbursement Process
5.5.2. The Brazilian Scenario
5.5.2.1. Regulatory Authority
5.5.2.2. Review / Approval Process
5.5.2.3. Reimbursement Landscape
5.5.2.3.1. Payer Mix
5.5.2.3.2. Reimbursement Process
5.5.3. The Chinese Scenario
5.5.3.1. Regulatory Authority
5.5.3.2. Review / Approval Process
5.5.3.3. Reimbursement Landscape
5.5.3.3.1. Payer Mix
5.5.3.3.2. Reimbursement Process
5.5.4. The Indian Scenario
5.5.4.1. Regulatory Authority
5.5.4.2. Review / Approval Process
5.5.4.3. Reimbursement Landscape
5.5.4.3.1. Payer Mix
5.5.5. The Israeli Scenario
5.5.5.1. Regulatory Authority
5.5.5.2. Review / Approval Process
5.5.5.3. Reimbursement Landscape
5.5.5.3.1. Payer Mix
5.5.6. The Japanese Scenario
5.5.6.1. Regulatory Authority
5.5.6.2. Review / Approval Process
5.5.6.3. Reimbursement Landscape
5.5.6.3.1. Payer Mix
5.5.6.3.2. Reimbursement Process
5.5.7. The New Zealand Scenario
5.5.7.1. Regulatory Authority
5.5.7.2. Review / Approval Process
5.5.7.3. Reimbursement Landscape
5.5.7.3.1. Payer Mix
5.5.7.3.2. Reimbursement Process
5.5.8. The Singaporean Scenario
5.5.8.1. Regulatory Authority
5.5.8.2. Review / Approval Process
5.5.8.3. Reimbursement Landscape
5.5.8.3.1. Payer Mix
5.5.8.3.2. Reimbursement Process
5.5.9. The South Korea Scenario
5.5.9.1. Regulatory Authority
5.5.9.2. Review / Approval Process
5.5.9.3. Reimbursement Landscape
5.5.9.3.1. Payer Mix
5.5.9.3.2. Reimbursement Process
5.5.10. The South African Scenario
5.5.10.1. Regulatory Authority
5.5.10.2. Review / Approval Process
5.5.10.3. Reimbursement Landscape
5.5.11. The Taiwanese Scenario
5.5.11.1. Regulatory Authority
5.5.11.2. Review / Approval Process
5.5.11.3. Reimbursement Landscape
5.5.11.3.1. Payer Mix
5.5.11.3.2. Reimbursement Process
5.5.12. The Thailand Scenario
5.5.12.1. Regulatory Authority
5.5.12.2. Review / Approval Process
5.5.12.3. Reimbursement Landscape
5.6. Comparison of Regional Regulatory Environment
5.7. Concluding Remarks

6. COMPETITIVE LANDSCAPE
6.1. Chapter Overview
6.2. CROs Offering Regulatory Affairs-Related Services for Medical Devices: List of Companies
6.2.1. Analysis by Year of Establishment
6.2.2. Analysis by Size of Employee Base
6.2.3. Analysis by Location of Headquarters
6.2.4. Analysis by Company Size and Geography
6.3. CROs Offering Regulatory Affairs-Related Services for Medical Devices: Information on Area of Specialization
6.3.1. Analysis by Area of Specialization
6.4. CROs Offering Medical Device Regulatory Services: Information on Type of Regulatory Affairs-Related Services Offered
6.4.1. Analysis by Type of Regulatory Affairs-Related Service Offered
6.4.2. Analysis by Year of Establishment, Geography and Type of Regulatory Affairs-Related Services Offered
6.5. CROs Offering Regulatory Affairs-Related Services for Medical Devices: Information on Type of Additional Services Offered
6.5.1. Analysis by Type of Additional Services Offered
6.6. CROs Offering Regulatory Affairs-Related Services for Medical Devices: Information on Device Class
6.6.1. Analysis by Device Class
6.7. CROs Offering Regulatory Affairs-Related Services for Medical Devices: Information on Type and Size of Clientele
6.7.1. Analysis by Type and Size of Clientele
6.8. CROs Offering Regulatory Affairs-Related Services for Medical Devices: Information on Medical Device Regulatory Compliance Authorities
6.8.1. Analysis by Medical Device Regulatory Compliance Authorities

6.9. CROs Offering Regulatory Affairs-Related Services for Medical Devices: Information on Geographical Reach (Region-wise)
6.9.1. Analysis by Geographical Reach (Region-Wise)

6.10. CROs Offering Regulatory Affairs-Related Services for Medical Devices: Information on Geographical Reach (Country-wise)
6.10.1. Analysis by Geographical Reach (Country-Wise)

7. COMPANY PROFILES
7.1. Chapter Overview

7.2. CROs Headquartered in North America
7.2.1. CTI Clinical Trial and Consulting (CTI) 
7.2.1.1. Company Overview
7.2.1.2. Service Portfolio
7.2.1.3. Future Outlook

7.2.2. Medpace
7.2.2.1. Company Overview
7.2.2.2 Financial Information
7.2.2.3. Service Portfolio
7.2.2.4. Future Outlook

7.2.3. NAMSA
7.2.3.1. Company Overview
7.2.3.2. Service Portfolio
7.2.3.3. Future Outlook

7.2.4. PAREXEL
7.2.4.1. Company Overview
7.2.4.2 Financial Information
7.2.4.3. Service Portfolio
7.2.4.4. Future Outlook

7.2.5. Premier Research
7.2.5.1. Company Overview
7.2.5.2. Service Portfolio
7.2.5.3. Future Outlook

7.2.6. Underwriters Laboratory (UL)
7.2.6.1. Company Overview
7.2.6.2. Service Portfolio
7.2.6.3. Future Outlook

7.3. CROs Headquartered in Europe
7.3.1. CROMSOURCE
7.3.1.1. Company Overview
7.3.1.2. Service Portfolio
7.3.1.3 Future Outlook

7.3.2. ICON 
7.3.2.1. Company Overview
7.3.2.2 Financial Information
7.3.2.3. Service Portfolio
7.3.2.4. Future Outlook

7.3.3. Intertek
7.3.3.1. Company Overview
7.3.3.2 Financial Information
7.3.3.3. Service Portfolio
7.3.3.4. Future Outlook

7.3.4. PharmaLex
7.3.4.1. Company Overview
7.3.4.2. Service Portfolio
7.3.4.3 Future Outlook
7.3.5. Société Générale de Surveillance (SGS)
7.3.5.1. Company Overview
7.3.5.2. Service Portfolio
7.3.5.3 Future Outlook

7.3.4. SteriPack
7.3.4.1. Company Overview
7.3.4.2. Service Portfolio
7.3.4.3 Future Outlook

7.4. CROs Headquartered in Asia-Pacific and Rest of the World
7.4.1. MIC Medical
7.4.1.1. Company Overview
7.4.1.2. Service Portfolio
7.4.1.3 Recent Developments

8. COMPETITIVE BENCHMARKING
8.1. Chapter Overview
8.2. Benchmark Analysis: Methodology
8.3. Region-wise Benchmark Analysis
8.3.1. North America, Peer Group I
8.3.2. North America, Peer Group II
8.3.3. North America, Peer Group III
8.3.4. North America, Peer Group IV
8.3.5. Europe, Peer Group V
8.3.6. Europe, Peer Group VI
8.3.7. Europe, Peer Group VII
8.3.8. Europe, Peer Group VIII
8.3.9. Asia Pacific and Rest of the World, Peer Group IX
8.3.10. Asia Pacific and Rest of the World, Peer Group X
8.3.11. Asia Pacific and Rest of the World, Peer Group XI
8.3.12. Asia Pacific and Rest of the World, Peer Group XII
8.4. Concluding Remarks

9. GUIDE TO REGULATORY OUTSOURCING MODELS
9.1. Chapter Overview
9.2. Guiding Models for Regulatory Outsourcing

9.2.1. Functional Service Providers (FSP) Model: Large Medical Device Developers
9.2.1.1. Vendor Evaluation

9.2.2. End-to-End Model: Small-Sized Medical Device Developers
9.2.2.1. Vendor Evaluation

9.2.3. Hybrid Model: Mid-Sized Medical Device Developers
9.2.3.1. Vendor Evaluation

9.3. Concluding Remarks

10. MEDICAL DEVICE REGULATORY AFFAIRS: KEY PERFORMANCE INDICATORS
10.1. Chapter Overview
10.2. Definition and Importance of Key Performance Indicators
10.3. Key Considerations for Selection of Key Performance Indicators
10.4. Types of Key Performance Indicators
10.4.1. Financial Indicators
10.4.1.1. Most Important KPIs
10.4.1.1.1. Financial Stability
10.4.1.1.2. Cost of Services Offered
10.4.1.1.3. Comparative Analysis of Financial Indicators

10.4.1.2. Industry Perspective
10.4.1.2.1. Sponsor (Big Pharma) Perspective
10.4.1.2.2. Contract Service Providers’ Perspective

10.4.2. Process / Capability Indicators
10.4.2.1. Most Important KPIs
10.4.2.1.1. Proximity to Sponsor
10.4.2.1.2. Capability to Innovate / Mitigate Risk
10.4.2.1.3. Strength of Service Portfolio
10.4.2.1.4. Comparative Analysis of Process / Capability Indicators
10.4.2.2. Industry Perspective
10.4.2.2.1. Sponsor (Big Pharma) Perspective
10.4.2.2.2. Contract Service Providers’ Perspective

10.4.3. Market Reputation Indicators
10.4.3.1. Most Important KPIs
10.4.3.1.1. Flexibility / Adaptability
10.4.3.1.2. Time Management
10.4.3.1.3. Quality / Reliability
10.4.3.1.4. Regulatory Compliance / Track Record
10.4.3.1.5. Comparative Analysis of Market Reputation Indicators

10.4.3.2. Industry Perspective
10.4.3.2.1. Sponsor (Big Pharma) Perspective
10.4.3.2.2. Contract Service Providers’ Perspective

10.5. Comparison of Key Performance Indicators
10.6. Concluding Remarks

11. MARKET FORECAST
11.1 Chapter Overview
11.2. Forecast Methodology and Key Assumptions
11.3. Overall Medical Device Regulatory Affairs Outsourcing Market, 2019-2030

11.4. Medical Device Regulatory Affairs Outsourcing Market: Distribution by Geography, 2019 and 2030
11.4.1. Medical Device Regulatory Affairs Outsourcing Market in North America, 2019-2030
11.4.1.1. Medical Device Regulatory Affairs Outsourcing Market in the US, 2019-2030
11.4.1.2. Medical Device Regulatory Affairs Outsourcing Market in Rest of North America, 2019-2030

11.4.2. Medical Device Regulatory Affairs Outsourcing Market in Europe, 2019-2030
11.4.2.1. Medical Device Regulatory Affairs Outsourcing Market in Italy, 2019-2030
11.4.2.2. Medical Device Regulatory Affairs Outsourcing Market in Germany, 2019-2030
11.4.2.3. Medical Device Regulatory Affairs Outsourcing Market in France, 2019-2030
11.4.2.4. Medical Device Regulatory Affairs Outsourcing Market in Spain, 2019-2030
11.4.2.5. Medical Device Regulatory Affairs Outsourcing Market in the UK, 2019-2030
11.4.2.6. Medical Device Regulatory Affairs Outsourcing Market in Rest of Europe, 2019-2030

11.4.3. Medical Device Regulatory Affairs Outsourcing Market in Asia-Pacific, 2019-2030
11.4.3.1. Medical Device Regulatory Affairs Outsourcing Market in China, 2019-2030
11.4.3.2. Medical Device Regulatory Affairs Outsourcing Market in Japan, 2019-2030
11.4.3.3. Medical Device Regulatory Affairs Outsourcing Market in India, 2019-2030
11.4.3.4. Medical Device Regulatory Affairs Outsourcing Market in Rest of the Asia-Pacific, 2019-2030

11.4.4. Medical Device Regulatory Affairs Outsourcing Market in Rest of the World, 2019-2030

11.5. Medical Device Regulatory Affairs Outsourcing Market: Distribution by Type of Regulatory Affairs-Related Service, 2019 and 2030
11.5.1. Medical Device Regulatory Affairs Outsourcing Market for GAP-Analysis, 2019-2030
11.5.2. Medical Device Regulatory Affairs Outsourcing Market for Legal Representation, 2019-2030
11.5.3. Medical Device Regulatory Affairs Outsourcing Market for Notified Body Selection, 2019-2030
11.5.4. Medical Device Regulatory Affairs Outsourcing Market for Product Labeling-Related Services, 2019-2030
11.5.5. Medical Device Regulatory Affairs Outsourcing Market for Product Registration and Clinical Trial Applications, 2019-2030
11.5.6. Medical Device Regulatory Affairs Outsourcing Market for Regulatory Writing and Publishing, 2019-2030
11.5.7. Medical Device Regulatory Affairs Outsourcing Market for Regulatory Document Submissions, 2019-2030
11.5.8. Medical Device Regulatory Affairs Outsourcing Market for Risk Management Service, 2019-2030
11.5.9. Medical Device Regulatory Affairs Outsourcing Market for Technical Dossier Set-Up, 2019-2030
11.5.10. Medical Device Regulatory Affairs Outsourcing Market for Vigilance & Medical Device Report, 2019-2030
11.6. Medical Device Regulatory Affairs Outsourcing Market: Distribution by Device Class, 2019 and 2030
11.6.1. Medical Device Regulatory Affairs Outsourcing Market for Class I Devices, 2019-2030
11.6.2. Medical Device Regulatory Affairs Outsourcing Market for Class II Devices, 2019-2030
11.6.3. Medical Device Regulatory Affairs Outsourcing Market for Class III Devices, 2019-2030

11.7. Medical Device Regulatory Affairs Outsourcing Market: Distribution by Therapeutic Area, 2019 and 2030
11.7.1. Medical Device Regulatory Affairs Outsourcing Market for Cardiovascular Disorders, 2019-2030
11.7.2. Medical Device Regulatory Affairs Outsourcing Market for Central Nervous System (CNS) Disorders, 2019-2030
11.7.3. Medical Device Regulatory Affairs Outsourcing Market for Metabolic Disorders, 2019-2030
11.7.4. Medical Device Regulatory Affairs Outsourcing Market for Oncological Disorders, 2019-2030
11.7.5. Medical Device Regulatory Affairs Outsourcing Market for Orthopedic Disorders, 2019-2030
11.7.6. Medical Device Regulatory Affairs Outsourcing Market for Ophthalmic Disorders, 2019-2030
11.7.7. Medical Device Regulatory Affairs Outsourcing Market for Pain Disorders, 2019-2030
11.7.8. Medical Device Regulatory Affairs Outsourcing Market for Respiratory Disorders, 2019-2030
11.7.9. Medical Device Regulatory Affairs Outsourcing Market for Other Therapeutic Areas, 2019-2030

11.8. Medical Device Regulatory Affairs Outsourcing Market: Distribution by Type of Regulatory Affairs-Related Service and Geography
11.8.1. Medical Device Regulatory Affairs Outsourcing Market for GAP-Analysis in North America, 2019-2030
11.8.2. Medical Device Regulatory Affairs Outsourcing Market for GAP-Analysis in Europe, 2019-2030
11.8.3. Medical Device Regulatory Affairs Outsourcing Market for GAP-Analysis in Asia-Pacific, 2019-2030
11.8.4. Medical Device Regulatory Affairs Outsourcing Market for GAP-Analysis in Rest of the World, 2019-2030
11.8.5. Medical Device Regulatory Affairs Outsourcing Market for Legal Representation in North America, 2019-2030
11.8.6. Medical Device Regulatory Affairs Outsourcing Market for Legal Representation in Europe, 2019-2030
11.8.7. Medical Device Regulatory Affairs Outsourcing Market for Legal Representation in Asia-Pacific, 2019-2030
11.8.8. Medical Device Regulatory Affairs Outsourcing Market for Legal Representation in Rest of the World, 2019-2030
11.8.9. Medical Device Regulatory Affairs Outsourcing Market for Notified Body Selection in North America, 2019-2030
11.8.10. Medical Device Regulatory Affairs Outsourcing Market for Notified Body Selection in Europe, 2019-2030
11.8.11. Medical Device Regulatory Affairs Outsourcing Market for Notified Body Selection in Asia-Pacific, 2019-2030
11.8.12. Medical Device Regulatory Affairs Outsourcing Market for Notified Body Selection in Rest of the World, 2019-2030
11.8.13. Medical Device Regulatory Affairs Outsourcing Market for Product Labeling-Related Services in North America, 2019-2030
11.8.14. Medical Device Regulatory Affairs Outsourcing Market for Product Labeling-Related Services in Europe, 2019-2030
11.8.15. Medical Device Regulatory Affairs Outsourcing Market for Product Labeling-Related Services in Asia-Pacific, 2019-2030
11.8.16. Medical Device Regulatory Affairs Outsourcing Market for Product Labeling-Related Services in Rest of the World, 2019-2030
11.8.17. Medical Device Regulatory Affairs Outsourcing Market for Product Registration and Clinical Trial Applications in North America, 2019-2030
11.8.18. Medical Device Regulatory Affairs Outsourcing Market for Product Registration and Clinical Trial Applications in Europe, 2019-2030
11.8.19. Medical Device Regulatory Affairs Outsourcing Market for Product Registration and Clinical Trial Applications in Asia-Pacific, 2019-2030
11.8.20. Medical Device Regulatory Affairs Outsourcing Market for Product Registration and Clinical Trial Applications in Rest of the World, 2019-2030
11.8.21. Medical Device Regulatory Affairs Outsourcing Market for Regulatory Writing and Publishing in North America, 2019-2030
11.8.22. Medical Device Regulatory Affairs Outsourcing Market for Regulatory Writing and Publishing in Europe, 2019-2030
11.8.23. Medical Device Regulatory Affairs Outsourcing Market for Regulatory Writing and Publishing in Asia-Pacific, 2019-2030
11.8.24. Medical Device Regulatory Affairs Outsourcing Market for Regulatory Writing and Publishing in Rest of the World, 2019-2030
11.8.25. Medical Device Regulatory Affairs Outsourcing Market for Regulatory Document Submissions in North America, 2019-2030
11.8.26. Medical Device Regulatory Affairs Outsourcing Market for Regulatory Document Submissions in Europe, 2019-2030
11.8.27. Medical Device Regulatory Affairs Outsourcing Market for Regulatory Document Submissions in Asia-Pacific, 2019-2030
11.8.28. Medical Device Regulatory Affairs Outsourcing Market for Regulatory Document Submissions in Rest of the World, 2019-2030
11.8.29. Medical Device Regulatory Affairs Outsourcing Market for Risk Management Service in North America, 2019-2030
11.8.30. Medical Device Regulatory Affairs Outsourcing Market for Risk Management Service in Europe, 2019-2030
11.8.311. Medical Device Regulatory Affairs Outsourcing Market for Risk Management Service in Asia-Pacific, 2019-2030
11.8.32. Medical Device Regulatory Affairs Outsourcing Market for Risk Management Service in Rest of the World, 2019-2030
11.8.33. Medical Device Regulatory Affairs Outsourcing Market for Technical Dossier Set-Up in North America, 2019-2030
11.8.34. Medical Device Regulatory Affairs Outsourcing Market for Technical Dossier Set-Up in Europe, 2019-2030
11.8.35. Medical Device Regulatory Affairs Outsourcing Market for Technical Dossier Set-Up in Asia-Pacific, 2019-2030
11.8.36. Medical Device Regulatory Affairs Outsourcing Market for Technical Dossier Set-Up in Rest of the World, 2019-2030
11.8.37. Medical Device Regulatory Affairs Outsourcing Market for Vigilance & Medical Device Report in North America, 2019-2030
11.8.38. Medical Device Regulatory Affairs Outsourcing Market for Vigilance & Medical Device Report in Europe, 2019-2030
11.8.39. Medical Device Regulatory Affairs Outsourcing Market for Vigilance & Medical Device Report in Asia-Pacific, 2019-2030
11.8.40. Medical Device Regulatory Affairs Outsourcing Market for Vigilance & Medical Device Report in Rest of the World, 2019-2030

11.9. Medical Device Regulatory Affairs Outsourcing Market: Distribution by Device Class and Geography
11.9.1. Medical Device Regulatory Affairs Outsourcing Market for Class I Devices in North America, 2019-2030
11.9.2. Medical Device Regulatory Affairs Outsourcing Market for Class I Devices in Europe, 2019-2030
11.9.3. Medical Device Regulatory Affairs Outsourcing Market for Class I Devices in Asia-Pacific, 2019-2030
11.9.4. Medical Device Regulatory Affairs Outsourcing Market for Class I Devices in Rest of the World, 2019-2030
11.9.5. Medical Device Regulatory Affairs Outsourcing Market for Class II Devices in North America, 2019-2030
11.9.6. Medical Device Regulatory Affairs Outsourcing Market for Class II Devices in Europe, 2019-2030
11.9.7. Medical Device Regulatory Affairs Outsourcing Market for Class II Devices in Asia-Pacific, 2019-2030
11.9.8. Medical Device Regulatory Affairs Outsourcing Market for Class II Devices in Rest of the World, 2019-2030
11.9.9. Medical Device Regulatory Affairs Outsourcing Market for Class III Devices in North America, 2019-2030
11.9.10. Medical Device Regulatory Affairs Outsourcing Market for Class III Devices in Europe, 2019-2030
11.9.11. Medical Device Regulatory Affairs Outsourcing Market for Class III Devices in Asia-Pacific, 2019-2030
11.9.12. Medical Device Regulatory Affairs Outsourcing Market for Class III Devices in Rest of the World, 2019-2030
11.10. Medical Device Regulatory Affairs Outsourcing Market: Distribution by Therapeutic Area and Geography
11.10.1. Medical Device Regulatory Affairs Outsourcing Market for Cardiovascular Disorders in North America, 2019-2030
11.10.2. Medical Device Regulatory Affairs Outsourcing Market for Cardiovascular Disorders in Europe, 2019-2030
11.10.3. Medical Device Regulatory Affairs Outsourcing Market for Cardiovascular Disorders in Asia-Pacific, 2019-2030
11.10.4. Medical Device Regulatory Affairs Outsourcing Market for Cardiovascular Disorders in Rest of the World, 2019-2030
11.10.5. Medical Device Regulatory Affairs Outsourcing Market for Central Nervous System Disorders in North America, 2019-2030
11.10.6. Medical Device Regulatory Affairs Outsourcing Market for Central Nervous System Disorders in Europe, 2019-2030
11.10.7. Medical Device Regulatory Affairs Outsourcing Market for Central Nervous System Disorders in Asia-Pacific, 2019-2030
11.10.8. Medical Device Regulatory Affairs Outsourcing Market for Central Nervous System Disorders in Rest of the World, 2019-2030
11.10.9. Medical Device Regulatory Affairs Outsourcing Market for Metabolic Disorders in North America, 2019-2030
11.10.10. Medical Device Regulatory Affairs Outsourcing Market for Metabolic Disorders in Europe, 2019-2030
11.10.11. Medical Device Regulatory Affairs Outsourcing Market for Metabolic Disorders in Asia-Pacific, 2019-2030
11.10.12. Medical Device Regulatory Affairs Outsourcing Market for Metabolic Disorders in Rest of the World, 2019-2030
11.10.13. Medical Device Regulatory Affairs Outsourcing Market for Oncological Disorders in North America, 2019-2030
11.10.14. Medical Device Regulatory Affairs Outsourcing Market for Oncological Disorders in Europe, 2019-2030
11.10.15. Medical Device Regulatory Affairs Outsourcing Market for Oncological Disorders in Asia-Pacific, 2019-2030
11.10.16. Medical Device Regulatory Affairs Outsourcing Market for Oncological Disorders in Rest of the World, 2019-2030
11.10.17. Medical Device Regulatory Affairs Outsourcing Market for Ophthalmological Disorders in North America, 2019-2030
11.10.18. Medical Device Regulatory Affairs Outsourcing Market for Ophthalmological Disorders in Europe, 2019-2030
11.10.19. Medical Device Regulatory Affairs Outsourcing Market for Ophthalmological Disorders in Asia-Pacific, 2019-2030
11.10.20. Medical Device Regulatory Affairs Outsourcing Market for Ophthalmological Disorders in Rest of the World, 2019-2030
11.10.21. Medical Device Regulatory Affairs Outsourcing Market for Orthopedic Disorders in North America, 2019-2030
11.10.22. Medical Device Regulatory Affairs Outsourcing Market for Orthopedic Disorders in Europe, 2019-2030
11.10.23. Medical Device Regulatory Affairs Outsourcing Market for Orthopedic Disorders in Asia-Pacific, 2019-2030
11.10.24. Medical Device Regulatory Affairs Outsourcing Market for Orthopedic Disorders in Rest of the World, 2019-2030
11.10.25. Medical Device Regulatory Affairs Outsourcing Market for Pain Disorders in North America, 2019-2030
11.10.26. Medical Device Regulatory Affairs Outsourcing Market for Pain Disorders in Europe, 2019-2030
11.10.27. Medical Device Regulatory Affairs Outsourcing Market for Pain Disorders in Asia-Pacific, 2019-2030
11.10.28. Medical Device Regulatory Affairs Outsourcing Market for Pain Disorders in Rest of the World, 2019-2030
11.10.29. Medical Device Regulatory Affairs Outsourcing Market for Respiratory Disorders in North America, 2019-2030
11.10.30. Medical Device Regulatory Affairs Outsourcing Market for Respiratory Disorders in Europe, 2019-2030
11.10.31. Medical Device Regulatory Affairs Outsourcing Market for Respiratory Disorders in Asia-Pacific, 2019-2030
11.10.32. Medical Device Regulatory Affairs Outsourcing Market for Respiratory Disorders in Rest of the World, 2019-2030
11.10.33. Medical Device Regulatory Affairs Outsourcing Market for Other Disorders in North America, 2019-2030
11.10.34. Medical Device Regulatory Affairs Outsourcing Market for Other Disorders in Europe, 2019-2030
11.10.35. Medical Device Regulatory Affairs Outsourcing Market for Other Disorders in Asia-Pacific, 2019-2030
11.10.36. Medical Device Regulatory Affairs Outsourcing Market for Other Disorders in Rest of the World, 2019-2030

11.11. Medical Device Regulatory Affairs Outsourcing Market: Distribution by Company Size, 2019-2030
11.11.1. Medical Device Regulatory Affairs Outsourcing Market for Small-Sized Companies, 2019-2030
11.11.2. Medical Device Regulatory Affairs Outsourcing Market for Mid-Sized Companies, 2019-2030
11.11.3. Medical Device Regulatory Affairs Outsourcing Market for Large Companies, 2019-2030

11.12. Concluding Remarks

12. CONCLUSION
12.1. Chapter Overview
12.2. Key Takeaways

13. SURVEY INSIGHTS
13.1. Chapter Overview
13.2. Company Specifics of Respondents
13.3. Designation of Respondents
13.4. Types of Regulatory Affairs-Related Services
13.5. Analysis by Geographical Reach
13.6. Type and Size of Clientele
13.7. Average Number of Projects
13.8. Proportion of Clients Outsourcing Regulatory Affairs-Related Services
13.9. Cost of Outsourcing Regulatory Affairs-Related Services
13.10. Current and Future Market Opportunity

14. EXECUTIVE INSIGHTS
14.1. Chapter Overview
14.2. A+ Science
14.2.1. Company Snapshot
14.2.2. Interview Transcript: Tania Persson, Business Development Manager

14.3. AtoZ-CRO
14.3.1. Company Snapshot
14.3.2. Interview Transcript: Alexa Foltin-Mertgen, Business Development Manager

14.4. CROMSOURCE
14.4.1. Company Snapshot
14.4.2. Interview Transcript: Troy Mccall, Chief Operating Officer

14.5. CW Research & Management
14.5.1. Company Snapshot
14.5.2. Interview Transcript: Christian Wolflehner, Managing Director, Clinical Trial Specialist

14.6. HungaroTrial
14.6.1 Company Snapshot
14.6.2. Interview Transcript: Antal Solyom, Director of Medical Device Unit
14.7. Metrics Research
14.7.1 Company Snapshot
14.7.2. Interview Transcript: Dr. Nazish Urooj, Senior Manager, Medical & Clinical Operations

14.8. Vyomus Consulting
14.8.1 Company Snapshot
14.8.2. Interview Transcript: Dr. C Omprakash, Technical Director and Partner

15. APPENDIX I: TABULATED DATA

16. APPENDIX II: LIST OF COMPANIES AND ORGANIZATIONS

List Of Figures

Figure 3.1. Medical Device Development Process
Figure 3.2. Types of Medical Device CROs
Figure 3.3. Services Offered by CROs
Figure 3.4. Key Challenges within the Medical Device Supply Chain
Figure 3.5. Risks / Challenges Associated with Regulatory Service CROs
Figure 4.1. Key Components of Medical Device Supply Chain
Figure 4.2. Key Technologies for Digitalization of Medical Device Supply Chain
Figure 4.3. Applications of Blockchain in Medical Device Supply Chain
Figure 5.1. Key Regulatory Authorities for Medical Devices
Figure 5.2. Medical Devices Review / Approval Process: US
Figure 5.3. Healthcare Insurance Coverage in the US: Distribution by Type of Coverage
Figure 5.4. Medical Devices National Coverage Determination Process: US
Figure 5.5. Medical Devices Review / Approval Process: Canada
Figure 5.6. Healthcare Insurance Coverage in Canada: Distribution by Type of Coverage
Figure 5.7. Medical Devices Review / Approval Process: Mexico
Figure 5.8. Regulatory Bodies in EU5 Countries
Figure 5.9. Steps involved in CE Marking Process
Figure 5.10. Medical Devices Review / Approval Process: Europe
Figure 5.11. Medical Devices Review / Approval Process: UK
Figure 5.12. Healthcare Insurance Coverage in the UK: Distribution by Type of Coverage
Figure 5.13. Medical Devices Reimbursement Process: UK
Figure 5.14. Healthcare Insurance Coverage in France: Distribution by Type of Coverage
Figure 5.15. Medical Devices Reimbursement Process: France
Figure 5.16. Healthcare Insurance Coverage in Germany: Distribution by Type of Coverage
Figure 5.17. Medical Devices Reimbursement Process for In-Patient Setting: Germany
Figure 5.18. Medical Devices Reimbursement Process for Out-Patient Care: Germany
Figure 5.19. Healthcare Insurance Coverage in Italy: Distribution by Type of Coverage
Figure 5.20. Medical Devices Reimbursement Process: Italy
Figure 5.21. Healthcare Insurance Coverage in Spain: Distribution by Type of Coverage
Figure 5.22. Medical Devices Reimbursement Process: Spain
Figure 5.23. Medical Devices Review / Approval Process: Australia
Figure 5.24. Healthcare Insurance Coverage in Australia: Percentage Distribution by Type of Coverage
Figure 5.25. Medical Devices Review / Approval Process: Brazil
Figure 5.26. Medical Devices Reimbursement Process: Brazil
Figure 5.27. Medical Devices Review / Approval Process: China
Figure 5.28. Healthcare Insurance Coverage in China: Percentage Distribution by Type of Coverage
Figure 5.29. Medical Devices Reimbursement Process: Shanghai
Figure 5.30. Medical Devices Review / Approval Process: India
Figure 5.31. Healthcare Insurance Coverage in Israel: Percentage Distribution by Type of Coverage
Figure 5.32. Medical Devices Review / Approval Process: Japan
Figure 5.33. Medical Devices Reimbursement Process: Japan
Figure 5.34. Healthcare Insurance Coverage in Japan: Percentage Distribution by Type of Coverage
Figure 5.35. New Medical Devices Reimbursement Process: Japan
Figure 5.36. Medical Devices Review / Approval Process: New Zealand
Figure 5.37. Healthcare Insurance Coverage in New Zealand: Percentage Distribution by Type of Coverage
Figure 5.38. Medical Devices Review / Approval Process: Singapore
Figure 5.39. Medical Devices Review / Approval Process: South Korea
Figure 5.40. Healthcare Insurance Coverage in South Korea: Percentage Distribution by Type of Coverage
Figure 5.41. Medical Devices Review / Approval Process: South Africa
Figure 5.42. Medical Devices Review / Approval Process: Taiwan
Figure 5.43. Healthcare Insurance Coverage in Taiwan: Percentage Distribution by Type of Coverage
Figure 5.44. Medical Devices Review / Approval Process: Thailand
Figure 5.45. Heat Map Analysis: Comparison of Regional Regulatory Control for Medical Devices
Figure 5.46. Regulatory Control for Medical Devices: Regional Analysis by Device Risk Category
Figure 6.1. Medical Devices Regulatory Affairs CROs: Distribution by Year of Establishment
Figure 6.2. Medical Devices Regulatory Affairs CROs: Distribution by Company Size
Figure 6.3. Medical Devices Regulatory Affairs CROs: Distribution by Geography
Figure 6.4. Medical Devices Regulatory Affairs CROs: Distribution by Company Size and Geography
Figure 6.5. Medical Device Regulatory Affairs CROs: Distribution by Area of Specialization
Figure 6.6. Medical Device Regulatory Affairs CROs: Distribution by Type of Regulatory Affairs-Related Services Offered
Figure 6.7. Medical Device Regulatory Affairs CROs: Distribution by Year of Establishment, Geography and Type of Regulatory Affairs-Related Services Offered
Figure 6.8. Medical Device Regulatory Affairs CROs: Distribution by Type of Additional Services Offered
Figure 6.9. Medical Device Regulatory Affairs CROs: Distribution by Device Class
Figure 6.10. Medical Device Regulatory Affairs CROs: Distribution by Type of Clientele
Figure 6.11. Medical Device Regulatory Affairs CROs: Distribution by Size of Clientele
Figure 6.12. Medical Device Regulatory Affairs CROs: Distribution by Type of Medical Device Regulatory Compliance Authorities
Figure 6.13. Medical Device Regulatory Affairs CROs: Distribution by Geographical Reach (Region-wise)
Figure 6.14. Medical Device Regulatory Affairs CROs: Distribution by Geographical Reach (Country-wise)
Figure 7.1. CTI: Service Portfolio
Figure 7.2. Medpace: Annual Revenues, 2014 – Q3 2019 (USD Million)
Figure 7.3. Medpace: Service Portfolio
Figure 7.4. NAMSA: Service Portfolio
Figure 7.5. PAREXEL: Annual Revenues, 2014 - 2017 (USD Million)
Figure 7.6. PAREXEL: Service Portfolio
Figure 7.7. Premier Research: Service Portfolio
Figure 7.8. UL: Service Portfolio
Figure 7.9. CROMSOURCE: Service Portfolio
Figure 7.10. ICON: Annual Revenues, 2014 - H1 2019 (USD Million)
Figure 7.11. ICON: Service Portfolio
Figure 7.12. Intertek: Annual Revenues, 2015 – H1 2019 (GBP Million)
Figure 7.13. Intertek: Service Portfolio
Figure 7.14. PharmaLex: Service Portfolio
Figure 7.15. SGS: Service Portfolio
Figure 7.16. SteriPack: Service Portfolio
Figure 7.17. MIC Medical: Service Portfolio
Figure 8.1. Benchmark Analysis: Distribution by Region and Company Size
Figure 8.2. Benchmark Analysis: North America, Peer Group I
Figure 8.3. Benchmark Analysis: North America, Peer Group II
Figure 8.4. Benchmark Analysis: North America, Peer Group III
Figure 8.5. Benchmark Analysis: North America, Peer Group IV
Figure 8.6. Benchmark Analysis: Europe, Peer Group V
Figure 8.7. Benchmark Analysis: Europe, Peer Group VI
Figure 8.8. Benchmark Analysis: Europe, Peer Group VII
Figure 8.9. Benchmark Analysis: Europe, Peer Group VIII
Figure 8.10. Benchmark Analysis: Asia Pacific and Rest of the World, Peer Group IX
Figure 8.11. Benchmark Analysis: Asia Pacific and Rest of the World, Peer Group X
Figure 8.12. Benchmark Analysis: Asia Pacific and Rest of the World, Peer Group XI
Figure 8.13. Benchmark Analysis: Asia Pacific and Rest of the World, Peer Group XII
Figure 8.14. Benchmark Analysis: Comparison across Peer Groups
Figure 9.1 Key Characteristics of Next-Generation FSP Model
Figure 9.2 Vendor Evaluation in FSP Model
Figure 9.3 Key Characteristics of End-to-End Model
Figure 9.4 Key Characteristics of Hybrid Model
Figure 10.1 Key Attributes for Selection of Key Performance Indicators (KPIs)
Figure 10.2 Types of KPIs
Figure 10.3 Financial Indicators: Comparative Analysis of KPIs considered by Big Pharma Companies
Figure 10.4 Financial Indicators: Sponsor (Big Pharma) Perspective
Figure 10.5 Financial Indicators: Contract Service Providers’ Perspective
Figure 10.6 Process / Capability Indicators: Comparative Analysis of KPIs of Big Pharma Companies
Figure 10.7 Process / Capability Indicators: Sponsor (Big Pharma) Perspective
Figure 10.8 Process / Capability Indicators: Contract Service Providers’ Perspective
Figure 10.9 Market Reputation Indicators: Comparative Analysis of KPIs of Big Pharma Companies
Figure 10.10 Market Reputation Indicators: Sponsor (Big Pharma) Perspective
Figure 10.11 Market Reputation Indicators: Contract Service Providers’ Perspective
Figure 10.12 Comparison of Key Factors for KPI Selection for Medical Devices
Figure 11.1. Overall Medical Device Regulatory Affairs Outsourcing Market, 2019-2030 (USD Million)
Figure11.2. Medical Device Regulatory Affairs Outsourcing Market: Distribution by Geography, 2019 and 2030 (USD Million)
Figure 11.3. Medical Device Regulatory Affairs Outsourcing Market in North America, 2019-2030 (USD Million)
Figure 11.4. Medical Device Regulatory Affairs Outsourcing Market in the US, 2019-2030 (USD Million)
Figure 11.5. Medical Device Regulatory Affairs Outsourcing Market in Rest of North America, 2019-2030 (USD Million)
Figure 11.6. Medical Device Regulatory Affairs Outsourcing Market in Europe, 2019-2030 (USD Million)
Figure 11.7. Medical Device Regulatory Affairs Outsourcing Market in Italy, 2019-2030 (USD Million)
Figure 11.8. Medical Device Regulatory Affairs Outsourcing Market in Germany, 2019-2030 (USD Million)
Figure 11.9. Medical Device Regulatory Affairs Outsourcing Market in France, 2019-2030 (USD Million)
Figure 11.10. Medical Device Regulatory Affairs Outsourcing Market in Spain, 2019-2030 (USD Million)
Figure 11.11. Medical Device Regulatory Affairs Outsourcing Market in the UK, 2019-2030 (USD Million)
Figure 11.12. Medical Device Regulatory Affairs Outsourcing Market in Rest of Europe, 2019-2030 (USD Million)
Figure 11.13. Medical Device Regulatory Affairs Outsourcing Market in Asia-Pacific, 2019-2030 (USD Million)
Figure 11.14. Medical Device Regulatory Affairs Outsourcing Market in China, 2019-2030 (USD Million)
Figure 11.15. Medical Device Regulatory Affairs Outsourcing Market in Japan, 2019-2030 (USD Million)
Figure 11.16. Medical Device Regulatory Affairs Outsourcing Market in India, 2019-2030 (USD Million)
Figure 11.17. Medical Device Regulatory Affairs Outsourcing Market in Rest of the Asia-Pacific, 2019-2030 (USD Million)
Figure 11.18. Medical Device Regulatory Affairs Outsourcing Market in Rest of the World, 2019-2030 (USD Million)
Figure 11.19. Medical Device Regulatory Affairs Outsourcing Market: Distribution by Type of Regulatory Affairs-Related Service, 2019 and 2030 (USD Million)
Figure 11.20. Medical Device Regulatory Affairs Outsourcing Market for GAP-Analysis, 2019-2030 (USD Million)
Figure 11.21. Medical Device Regulatory Affairs Outsourcing Market for Legal Representation, 2019-2030 (USD Million)
Figure 11.22. Medical Device Regulatory Affairs Outsourcing Market for Notified Body Selection, 2019-2030 (USD Million)
Figure 11.23. Medical Device Regulatory Affairs Outsourcing Market for Product Labeling-Related Services, 2019-2030 (USD Million)
Figure 11.24. Medical Device Regulatory Affairs Outsourcing Market for Product Registration and Clinical Trial Applications, 2019-2030 (USD Million)
Figure 11.25. Medical Device Regulatory Affairs Outsourcing Market for Regulatory Writing and Publishing, 2019-2030 (USD Million)
Figure 11.26. Medical Device Regulatory Affairs Outsourcing Market for Regulatory Document Submissions, 2019-2030 (USD Million)
Figure 11.27. Medical Device Regulatory Affairs Outsourcing Market for Risk Management Service, 2019-2030 (USD Million)
Figure 11.28. Medical Device Regulatory Affairs Outsourcing Market for Technical Dossier Set-Up, 2019-2030 (USD Million)
Figure 11.29. Medical Device Regulatory Affairs Outsourcing Market for Vigilance & Medical Device Report, 2019-2030 (USD Million)
Figure 11.30. Medical Device Regulatory Affairs Outsourcing Market: Distribution by Device Class, 2019 and 2030 (USD Million)
Figure 11.31. Medical Device Regulatory Affairs Outsourcing Market for Class I Devices, 2019-2030 (USD Million)
Figure 11.32. Medical Device Regulatory Affairs Outsourcing Market for Class II Devices, 2019-2030 (USD Million)
Figure 11.33. Medical Device Regulatory Affairs Outsourcing Market for Class III Devices, 2019-2030 (USD Million)
Figure 11.34. Medical Device Regulatory Affairs Outsourcing Market: Distribution by Therapeutic Area, 2019 and 2030 (USD Million)
Figure 11.35. Medical Device Regulatory Affairs Outsourcing Market for Cardiovascular Disorders, 2019-2030 (USD Million)
Figure 11.36. Medical Device Regulatory Affairs Outsourcing Market for Central Nervous System Disorders, 2019-2030 (USD Million)
Figure 11.37. Medical Device Regulatory Affairs Outsourcing Market for Metabolic Disorders, 2019-2030 (USD Million)
Figure 11.38. Medical Device Regulatory Affairs Outsourcing Market for Oncological Disorders, 2019-2030 (USD Million)
Figure 11.39. Medical Device Regulatory Affairs Outsourcing Market for Orthopedic Disorders, 2019-2030 (USD Million)
Figure 11.40. Medical Device Regulatory Affairs Outsourcing Market for Ophthalmic Disorders, 2019-2030 (USD Million)
Figure 11.41. Medical Device Regulatory Affairs Outsourcing Market for Pain Disorders, 2019-2030 (USD Million)
Figure 11.42. Medical Device Regulatory Affairs Outsourcing Market for Respiratory Disorders, 2019-2030 (USD Million)
Figure 11.43. Medical Device Regulatory Affairs Outsourcing Market for Other Therapeutic Areas, 2019-2030 (USD Million)
Figure 11.44. Medical Device Regulatory Affairs Outsourcing Market for GAP-Analysis in North America, 2019-2030 (USD Million)
Figure 11.45. Medical Device Regulatory Affairs Outsourcing Market for GAP-Analysis in Europe, 2019-2030 (USD Million)
Figure 11.46. Medical Device Regulatory Affairs Outsourcing Market for GAP-Analysis in Asia-Pacific, 2019-2030 (USD Million)
Figure 11.47. Medical Device Regulatory Affairs Outsourcing Market for GAP-Analysis in Rest of the World, 2019-2030 (USD Million)
Figure 11.48. Medical Device Regulatory Affairs Outsourcing Market for Legal Representation in North America, 2019-2030 (USD Million)
Figure 11.49. Medical Device Regulatory Affairs Outsourcing Market for Legal Representation in Europe, 2019-2030 (USD Million)
Figure 11.50. Medical Device Regulatory Affairs Outsourcing Market for Legal Representation in Asia-Pacific, 2019-2030 (USD Million)
Figure 11.51. Medical Device Regulatory Affairs Outsourcing Market for Legal Representation in Rest of the World, 2019-2030 (USD Million)
Figure 11.52. Medical Device Regulatory Affairs Outsourcing Market for Notified Body Selection in North America, 2019-2030 (USD Million)
Figure 11.53. Medical Device Regulatory Affairs Outsourcing Market for Notified Body Selection in Europe, 2019-2030 (USD Million)
Figure 11.54. Medical Device Regulatory Affairs Outsourcing Market for Notified Body Selection in Asia-Pacific, 2019-2030 (USD Million)
Figure 11.55. Medical Device Regulatory Affairs Outsourcing Market for Notified Body Selection in Rest of the World, 2019-2030 (USD Million)
Figure 11.56. Medical Device Regulatory Affairs Outsourcing Market for Product Labeling-Related Services in North America, 2019-2030 (USD Million)
Figure 11.57. Medical Device Regulatory Affairs Outsourcing Market for Product Labeling-Related Services in Europe, 2019-2030 (USD Million)
Figure 11.58. Medical Device Regulatory Affairs Outsourcing Market for Product Labeling-Related Services in Asia-Pacific, 2019-2030 (USD Million)
Figure 11.59. Medical Device Regulatory Affairs Outsourcing Market for Product Labeling-Related Services in Rest of the World, 2019-2030 (USD Million)
Figure 11.60. Medical Device Regulatory Affairs Outsourcing Market for Product Registration and Clinical Trial Applications in North America, 2019-2030 (USD Million)
Figure 11.61. Medical Device Regulatory Affairs Outsourcing Market for Product Registration and Clinical Trial Applications in Europe, 2019-2030 (USD Million)
Figure 11.62. Medical Device Regulatory Affairs Outsourcing Market for Product Registration and Clinical Trial Applications in Asia-Pacific, 2019-2030 (USD Million)
Figure 11.63. Medical Device Regulatory Affairs Outsourcing Market for Product Registration and Clinical Trial Applications in Rest of the World, 2019-2030 (USD Million)
Figure 11.64. Medical Device Regulatory Affairs Outsourcing Market for Regulatory Writing and Publishing in North America, 2019-2030 (USD Million)
Figure 11.65. Medical Device Regulatory Affairs Outsourcing Market for Regulatory Writing and Publishing in Europe, 2019-2030 (USD Million)
Figure 11.66. Medical Device Regulatory Affairs Outsourcing Market for Regulatory Writing and Publishing in Asia-Pacific, 2019-2030 (USD Million)
Figure 11.67. Medical Device Regulatory Affairs Outsourcing Market for Regulatory Writing and Publishing in Rest of the World, 2019-2030 (USD Million)
Figure 11.68. Medical Device Regulatory Affairs Outsourcing Market for Regulatory Document Submissions in North America, 2019-2030 (USD Million)
Figure 11.69. Medical Device Regulatory Affairs Outsourcing Market for Regulatory Document Submissions in Europe, 2019-2030 (USD Million)
Figure 11.70. Medical Device Regulatory Affairs Outsourcing Market for Regulatory Document Submissions in Asia-Pacific, 2019-2030 (USD Million)
Figure 11.71. Medical Device Regulatory Affairs Outsourcing Market for Regulatory Document Submissions in Rest of the World, 2019-2030 (USD Million)
Figure 11.72. Medical Device Regulatory Affairs Outsourcing Market for Risk Management Service in North America, 2019-2030 (USD Million)
Figure 11.73. Medical Device Regulatory Affairs Outsourcing Market for Risk Management Service in Europe, 2019-2030 (USD Million)
Figure 11.74. Medical Device Regulatory Affairs Outsourcing Market for Risk Management Service in Asia-Pacific, 2019-2030 (USD Million)
Figure 11.75. Medical Device Regulatory Affairs Outsourcing Market for Risk Management Service in Rest of the World, 2019-2030 (USD Million)
Figure 11.76. Medical Device Regulatory Affairs Outsourcing Market for Technical Dossier Set-Up in North America, 2019-2030 (USD Million)
Figure 11.77. Medical Device Regulatory Affairs Outsourcing Market for Technical Dossier Set-Up in Europe, 2019-2030 (USD Million)
Figure 11.78. Medical Device Regulatory Affairs Outsourcing Market for Technical Dossier Set-Up in Asia-Pacific, 2019-2030 (USD Million)
Figure 11.79. Medical Device Regulatory Affairs Outsourcing Market for Technical Dossier Set-Up in Rest of the World, 2019-2030 (USD Million)
Figure 11.80. Medical Device Regulatory Affairs Outsourcing Market for Vigilance & Medical Device Report in North America, 2019-2030 (USD Million)
Figure 11.81. Medical Device Regulatory Affairs Outsourcing Market for Vigilance & Medical Device Report in Europe, 2019-2030 (USD Million)
Figure 11.82. Medical Device Regulatory Affairs Outsourcing Market for Vigilance & Medical Device Report in Asia-Pacific, 2019-2030 (USD Million)
Figure 11.83. Medical Device Regulatory Affairs Outsourcing Market for Vigilance & Medical Device Report in Rest of the World, 2019-2030 (USD Million)
Figure 11.84. Medical Device Regulatory Affairs Outsourcing Market for Class I Devices in North America, 2019-2030 (USD Million)
Figure 11.85. Medical Device Regulatory Affairs Outsourcing Market for Class I Devices in Europe, 2019-2030 (USD Million)
Figure 11.86. Medical Device Regulatory Affairs Outsourcing Market for Class I Devices in Asia-Pacific, 2019-2030 (USD Million)
Figure 11.87. Medical Device Regulatory Affairs Outsourcing Market for Class I Devices in Rest of the World, 2019-2030 (USD Million)
Figure 11.88. Medical Device Regulatory Affairs Outsourcing Market for Class II Devices in North America, 2019-2030 (USD Million)
Figure 11.89. Medical Device Regulatory Affairs Outsourcing Market for Class II Devices in Europe, 2019-2030 (USD Million)
Figure 11.90. Medical Device Regulatory Affairs Outsourcing Market for Class II Devices in Asia-Pacific, 2019-2030 (USD Million)
Figure 11.91. Medical Device Regulatory Affairs Outsourcing Market for Class II Devices in Rest of the World, 2019-2030 (USD Million)
Figure 11.92. Medical Device Regulatory Affairs Outsourcing Market for Class III Devices in North America, 2019-2030 (USD Million)
Figure 11.93. Medical Device Regulatory Affairs Outsourcing Market for Class III Devices in Europe, 2019-2030 (USD Million)
Figure 11.94. Medical Device Regulatory Affairs Outsourcing Market for Class III Devices in Asia-Pacific, 2019-2030 (USD Million)
Figure 11.95. Medical Device Regulatory Affairs Outsourcing Market for Class III Devices in Rest of the World, 2019-2030 (USD Million)
Figure 11.96. Medical Device Regulatory Affairs Outsourcing Market for Cardiovascular Disorders in North America, 2019-2030 (USD Million)
Figure 11.97. Medical Device Regulatory Affairs Outsourcing Market for Cardiovascular Disorders in Europe, 2019-2030 (USD Million)
Figure 11.98. Medical Device Regulatory Affairs Outsourcing Market for Cardiovascular Disorders in Asia-Pacific, 2019-2030 (USD Million)
Figure 11.99. Medical Device Regulatory Affairs Outsourcing Market for Cardiovascular Disorders in Rest of the World, 2019-2030 (USD Million)
Figure 11.100. Medical Device Regulatory Affairs Outsourcing Market for Central Nervous System Disorders in North America, 2019-2030 (USD Million)
Figure 11.101. Medical Device Regulatory Affairs Outsourcing Market for Central Nervous System Disorders in Europe, 2019-2030 (USD Million)
Figure 11.102. Medical Device Regulatory Affairs Outsourcing Market for Central Nervous System Disorders in Asia-Pacific, 2019-2030 (USD Million)
Figure 11.103. Medical Device Regulatory Affairs Outsourcing Market for Central Nervous System Disorders in Rest of the World, 2019-2030 (USD Million)
Figure 11.104. Medical Device Regulatory Affairs Outsourcing Market for Metabolic Disorders in North America, 2019-2030 (USD Million)
Figure 11.105. Medical Device Regulatory Affairs Outsourcing Market for Metabolic Disorders in Europe, 2019-2030 (USD Million)
Figure 11.106. Medical Device Regulatory Affairs Outsourcing Market for Metabolic Disorders in Asia-Pacific, 2019-2030 (USD Million)
Figure 11.107. Medical Device Regulatory Affairs Outsourcing Market for Metabolic Disorders in Rest of the World, 2019-2030 (USD Million)
Figure 11.108. Medical Device Regulatory Affairs Outsourcing Market for Oncological Disorders in North America, 2019-2030 (USD Million)
Figure 11.109. Medical Device Regulatory Affairs Outsourcing Market for Oncological Disorders in Europe, 2019-2030 (USD Million)
Figure 11.110. Medical Device Regulatory Affairs Outsourcing Market for Oncological Disorders in Asia-Pacific, 2019-2030 (USD Million)
Figure 11.111. Medical Device Regulatory Affairs Outsourcing Market for Oncological Disorders in Rest of the World, 2019-2030 (USD Million)
Figure 11.112. Medical Device Regulatory Affairs Outsourcing Market for Ophthalmological Disorders in North America, 2019-2030 (USD Million)
Figure 11.113. Medical Device Regulatory Affairs Outsourcing Market for Ophthalmological Disorders in Europe, 2019-2030 (USD Million)
Figure 11.114. Medical Device Regulatory Affairs Outsourcing Market for Ophthalmological Disorders in Asia-Pacific, 2019-2030 (USD Million)
Figure 11.115. Medical Device Regulatory Affairs Outsourcing Market for Ophthalmological Disorders in Rest of the World, 2019-2030 (USD Million)
Figure 11.116. Medical Device Regulatory Affairs Outsourcing Market for Orthopedic Disorders in North America, 2019-2030 (USD Million)
Figure 11.117. Medical Device Regulatory Affairs Outsourcing Market for Orthopedic Disorders in Europe, 2019-2030 (USD Million)
Figure 11.118. Medical Device Regulatory Affairs Outsourcing Market for Orthopedic Disorders in Asia-Pacific, 2019-2030 (USD Million)
Figure 11.119. Medical Device Regulatory Affairs Outsourcing Market for Orthopedic Disorders in Rest of the World, 2019-2030 (USD Million)
Figure 11.120. Medical Device Regulatory Affairs Outsourcing Market for Pain Disorders in North America, 2019-2030 (USD Million)
Figure 11.121. Medical Device Regulatory Affairs Outsourcing Market for Pain Disorders in Europe, 2019-2030 (USD Million)
Figure 11.122. Medical Device Regulatory Affairs Outsourcing Market for Pain Disorders in Asia-Pacific, 2019-2030 (USD Million)
Figure 11.123. Medical Device Regulatory Affairs Outsourcing Market for Pain Disorders in Rest of the World, 2019-2030 (USD Million)
Figure 11.124. Medical Device Regulatory Affairs Outsourcing Market for Respiratory Disorders in North America, 2019-2030 (USD Million)
Figure 11.125. Medical Device Regulatory Affairs Outsourcing Market for Respiratory Disorders in Europe, 2019-2030 (USD Million)
Figure 11.126. Medical Device Regulatory Affairs Outsourcing Market for Respiratory Disorders in Asia-Pacific, 2019-2030 (USD Million)
Figure 11.127. Medical Device Regulatory Affairs Outsourcing Market for Respiratory Disorders in Rest of the World, 2019-2030 (USD Million)
Figure 11.128. Medical Device Regulatory Affairs Outsourcing Market for Other Disorders in North America, 2019-2030 (USD Million)
Figure 11.129. Medical Device Regulatory Affairs Outsourcing Market for Other Disorders in Europe, 2019-2030 (USD Million)
Figure 11.130. Medical Device Regulatory Affairs Outsourcing Market for Other Disorders in Asia-Pacific, 2019-2030 (USD Million)
Figure 11.131. Medical Device Regulatory Affairs Outsourcing Market for Other Disorders in Rest of the World, 2019-2030 (USD Million)
Figure 11.132. Medical Device Regulatory Affairs Outsourcing Market: Distribution by Company Size, 2019-2030
Figure 11.133. Medical Device Regulatory Affairs Outsourcing Market for Small-Sized Companies, 2019-2030
Figure 11.134. Medical Device Regulatory Affairs Outsourcing Market for Mid-Sized Companies, 2019-2030
Figure 11.135. Medical Device Regulatory Affairs Outsourcing Market for Large Companies, 2019-2030
Figure 11.136. Overall Medical Device Regulatory Affairs Outsourcing Market: Comparative Evolution Scenarios, 2019, 2025 and 2030 (USD Million)
Figure 13.1. Survey Insights: Distribution of Respondents by Year of Establishment of Company
Figure 13.2. Survey Insights: Distribution of Respondents by Employee Size
Figure 13.3. Survey Insights: Distribution of Respondents by Location of Company Headquarters (Continent-Wise)
Figure 13.4. Survey Insights: Distribution of Respondents by Location of Company Headquarters (Country-Wise)
Figure 13.5. Survey Insights: Distribution by Designation and Seniority Level
Figure 13.6. Survey Insights: Distribution by Types of Services
Figure 13.7. Survey Insights: Distribution by Geographical Reach
Figure 13.8. Survey Insights: Distribution by Type and Size of Clientele
Figure 13.9. Survey Insights: Distribution by Number of Projects
Figure 13.10. Survey Insights: Distribution by Proportion of Clients Outsourcing Regulatory Affairs-Related Services
Figure 13.11. Survey Insights: Distribution by Current and Future Market Opportunity

List Of Tables

Table 3.1. Key Drivers for Outsourcing Regulatory Affairs-Related Operations for Medical Devices
Table 3.2. Comparison of Key Factors for Regulatory CRO Selection for Medical Devices: Harvey Ball Analysis
Table 5.1. General Guidelines for Market Authorization and Reimbursement for Medical Devices
Table 5.2. Device Classification: US
Table 5.3. Device Classification: Canada
Table 5.4. Data Requirements and Characteristics of Province-wide HTA Processes in Canada
Table 5.5. Device Classification: Mexico
Table 5.6. Device Classification: Europe
Table 5.7. List of CE Directives in Europe
Table 5.8. Conformity Assessment Modules in Europe
Table 5.9. Device Classification: Australia
Table 5.10. Medical Devices Reimbursement and Pricing Approval Process: Australia
Table 5.11. Device Classification: Brazil
Table 5.12. Device Classification: China
Table 5.13. Device Classification: India
Table 5.14. Device Classification: Japan
Table 5.15. Medical Devices Reimbursement Categories
Table 5.16. Device Classification: New Zealand
Table 5.17. Device Classification: Singapore
Table 5.18. Device Classification: South Korea
Table 5.19. Device Classification: South Africa
Table 5.20. Device Classification: Thailand
Table 5.21. Medical Devices Regulatory Landscape Summary
Table 5.22. Medical Devices Reimbursement Landscape Summary
Table 6.1. Medical Devices Regulatory Affairs CROs: List of Players
Table 6.2. Medical Devices Regulatory Affairs CROs: Information on Area of Specialization
Table 6.3. Medical Devices Regulatory Affairs CROs: Information on Type of Regulatory Affairs-Related Services Offered
Table 6.4. Medical Devices Regulatory Affairs CROs: Information on Type of Additional Services Offered
Table 6.5. Medical Devices Regulatory Affairs CROs: Information on Device Class
Table 6.6. Medical Devices Regulatory Affairs CROs: Information on Type and Size of Clientele
Table 6.7. Medical Devices Regulatory Affairs CROs: Information on Medical Device Regulatory Compliance Authorities
Table 6.8. Medical Devices Regulatory Affairs CROs: Information on Geographical Reach (Region-Wise)
Table 6.9. Medical Devices Regulatory Affairs CROs: Information on Geographical Reach (Country-wise)
Table 7.1. Regulatory Affairs-Related Services for Medical Devices: List of Companies Profiled
Table 7.2. CTI: Company Snapshot
Table 7.3. CTI: Recent Developments and Future Outlook
Table 7.4. Medpace: Company Snapshot
Table 7.5. Medpace: Recent Developments and Future Outlook
Table 7.6. NAMSA: Company Snapshot
Table 7.7. NAMSA: Recent Developments and Future Outlook
Table 7.8. PAREXEL: Company Snapshot
Table 7.9. PAREXEL: Recent Developments and Future Outlook
Table 7.10. Premier Research: Company Snapshot
Table 7.11. Premier Research: Recent Developments and Future Outlook
Table 7.12. Underwriters Laboratory: Company Snapshot
Table 7.13. Underwriters Laboratory: Recent Developments and Future Outlook
Table 7.14. CROMSOURCE: Company Snapshot
Table 7.15. CROMSOURCE: Recent Developments and Future Outlook
Table 7.16. ICON: Company Snapshot
Table 7.17. ICON: Recent Developments and Future Outlook
Table 7.18. Intertek: Company Snapshot
Table 7.19. Intertek: Recent Developments and Future Outlook
Table 7.20. PharmaLex: Company Snapshot
Table 7.21. PharmaLex: Recent Developments and Future Outlook
Table 7.22. Société Générale de Surveillance (SGS): Company Snapshot
Table 7.23. Société Générale de Surveillance (SGS): Recent Developments and Future Outlook
Table 7.24. SteriPack: Company Snapshot
Table 7.25. SteriPack: Recent Developments and Future Outlook
Table 7.26. MIC Medical: Company Snapshot
Table 8.1. Benchmark Analysis: Peer Groups
Table 9.1. Comparison between Different Regulatory Outsourcing Models
Table 12.1. Medical Device Regulatory Affairs Outsourcing: Summary of the Report
Table 13.1. Survey Insights: Overview of Respondents
Table 13.2. Survey Insights: Designations and Seniority Levels
Table 13.3. Survey Insights: Types of Regulatory Affairs-Related Services
Table 13.4. Survey Insights: Geographical Reach
Table 13.5. Survey Insights: Type and Size of Clientele
Table 13.6. Survey Insights: Distribution by Number of Projects
Table 13.7. Survey Insights: Proportion of Clients Outsourcing Regulatory Affairs-Related Services
Table 13.8. Survey Insights: Outsourcing Cost
Table 13.9. Survey Insights: Current and Future Market Opportunity
Table 14.1. A+ Science: Company Snapshot
Table 14.2. Atoz-Cro: Company Snapshot
Table 14.3. CROMSOURCE: Company Snapshot
Table 14.4. CW Research & Management: Company Snapshot
Table 14.5. HungaroTrial: Company Snapshot
Table 14.6. Metrics Research: Company Snapshot
Table 14.7. Vyomus Consulting: Company Snapshot
Table 15.1. Key Challenges within the Medical Device Supply Chain
Table 15.2. Healthcare Insurance Coverage in the US: Distribution by Type of Coverage
Table 15.3. Healthcare Insurance Coverage in Canada: Distribution by Type of Coverage
Table 15.4. Healthcare Insurance Coverage in the UK: Distribution by Type of Coverage
Table 15.5. Healthcare Insurance Coverage in France: Distribution by Type of Coverage
Table 15.6. Healthcare Insurance Coverage in Germany: Distribution by Type of Coverage
Table 15.7. Healthcare Insurance Coverage in Italy: Distribution by Type of Coverage
Table 15.8. Healthcare Insurance Coverage in Spain: Distribution by Type of Coverage
Table 15.9. Healthcare Insurance Coverage in Australia: Percentage Distribution by Type of Coverage
Table 15.10. Healthcare Insurance Coverage in China: Percentage Distribution by Type of Coverage
Table 15.11. Healthcare Insurance Coverage in Israel: Percentage Distribution by Type of Coverage
Table 15.12. Healthcare Insurance Coverage in Japan: Percentage Distribution by Type of Coverage
Table 15.13. Healthcare Insurance Coverage in New Zealand: Percentage Distribution by Type of Coverage
Table 15.14. Healthcare Insurance Coverage in South Korea: Percentage Distribution by Type of Coverage
Table 15.15. Healthcare Insurance Coverage in Taiwan: Percentage Distribution by Type of Coverage
Table 15.16. Medical Devices Regulatory Affairs CROs: Distribution by Year of Establishment
Table 15.17. Medical Devices Regulatory Affairs CROs: Distribution by Company Size
Table 15.18. Medical Devices Regulatory Affairs CROs: Distribution by Geography
Table 15.19 Medical Devices Regulatory Affairs CROs: Distribution by Company Size and Geography
Table 15.20. Medical Device Regulatory Affairs CROs: Distribution by Area of Specialization
Table 15.21. Medical Devices Regulatory Affairs CROs: Distribution by Type of Regulatory Affairs-Related Services Offered
Table 15.22. Medical Devices Regulatory Affairs CROs: Distribution by Year of Establishment, Geography and Type of Regulatory Affairs-Related Services Offered
Table 15.23. Medical Devices Regulatory Affairs CROs: Distribution by Type of Additional Services Offered
Table 15.24. Medical Devices Regulatory Affairs CROs: Distribution by Device Class
Table 15.25. Medical Devices Regulatory Affairs CROs: Distribution by Type of Clientele
Table 15.26. Medical Devices Regulatory Affairs CROs: Distribution by Size of Clientele
Table 15.27. Medical Devices Regulatory Affairs CROs: Distribution by Type of Medical Device Regulatory Compliance Authorities
Table 15.28. Medical Devices Regulatory Affairs CROs: Distribution by Geographical Reach (Region-wise)
Table 15.29. Medical Devices Regulatory Affairs CROs: Distribution by Geographical Reach (Country-wise)
Table 15.30. Medpace: Annual Revenues, 2014-2018 (USD Million)
Table 15.31. PAREXEL: Annual Revenues, 2014-2017 (USD Million)
Table 15.32. ICON: Annual Revenues, 2014 - H1 2019 (USD Million)
Table 15.33. Intertek: Annual Revenues, 2015 – H1 2019 (GBP Million)
Table 15.34. Benchmark Analysis: Distribution by Region and Size of Employee Base
Table 15.35. Benchmark Analysis: North America, Peer Group I
Table 15.36. Benchmark Analysis: North America, Peer Group II
Table 15.37. Benchmark Analysis: North America, Peer Group III
Table 15.38. Benchmark Analysis: North America, Peer Group IV
Table 15.39. Benchmark Analysis: Europe, Peer Group V
Table 15.40. Benchmark Analysis: Europe, Peer Group VI
Table 15.41. Benchmark Analysis: Europe, Peer Group VII
Table 15.42. Benchmark Analysis: Europe, Peer Group VIII
Table 15.43. Benchmark Analysis: Asia Pacific and Rest of the World, Peer Group IX
Table 15.44. Benchmark Analysis: Asia Pacific and Rest of the World, Peer Group X
Table 15.45. Benchmark Analysis: Asia Pacific and Rest of the World, Peer Group XI
Table 15.46. Benchmark Analysis: Asia Pacific and Rest of the World, Peer Group XII
Table 15.47. Benchmark Analysis: Comparison across Peer Groups
Table 15.48. Overall Medical Device Regulatory Affairs Outsourcing Market, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.49. Medical Device Regulatory Affairs Outsourcing Market, 2019 and 2030: Distribution by Geography (USD Million)
Table 15.50. Medical Device Regulatory Affairs Outsourcing Market in North America, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.51. Medical Device Regulatory Affairs Outsourcing Market in the US, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.52. Medical Device Regulatory Affairs Outsourcing Market in Rest of North America, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.53. Medical Device Regulatory Affairs Outsourcing Market in Europe, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.54. Medical Device Regulatory Affairs Outsourcing Market in Italy, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.55. Medical Device Regulatory Affairs Outsourcing Market in Germany, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.56. Medical Device Regulatory Affairs Outsourcing Market in France, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.57. Medical Device Regulatory Affairs Outsourcing Market in Spain, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.58. Medical Device Regulatory Affairs Outsourcing Market in the UK, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.59. Medical Device Regulatory Affairs Outsourcing Market in Rest of Europe, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.60. Medical Device Regulatory Affairs Outsourcing Market in Asia-Pacific, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.61. Medical Device Regulatory Affairs Outsourcing Market in China, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.62. Medical Device Regulatory Affairs Outsourcing Market in Japan, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.63. Medical Device Regulatory Affairs Outsourcing Market in India, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.64. Medical Device Regulatory Affairs Outsourcing Market in Rest of the Asia-Pacific, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.65. Medical Device Regulatory Affairs Outsourcing Market in Rest of the World, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.66. Medical Device Regulatory Affairs Outsourcing Market, 2019 and 2030: Distribution by Type of Regulatory Affairs-Related Service (USD Million)
Table 15.67. Medical Device Regulatory Affairs Outsourcing Market for GAP-Analysis, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.68. Medical Device Regulatory Affairs Outsourcing Market for Legal Representation, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.69. Medical Device Regulatory Affairs Outsourcing Market for Notified Body Selection, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.70. Medical Device Regulatory Affairs Outsourcing Market for Product Labeling-Related Services, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.71. Medical Device Regulatory Affairs Outsourcing Market for Product Registration and Clinical Trial Applications, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.72. Medical Device Regulatory Affairs Outsourcing Market for Regulatory Writing and Publishing, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.73. Medical Device Regulatory Affairs Outsourcing Market for Regulatory Document Submissions, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.74. Medical Device Regulatory Affairs Outsourcing Market for Risk Management Service, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.75. Medical Device Regulatory Affairs Outsourcing Market for Technical Dossier Set-Up, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.76. Medical Device Regulatory Affairs Outsourcing Market for Vigilance & Medical Device Report, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.77. Medical Device Regulatory Affairs Outsourcing Market: Distribution by Device Class, 2019 and 2030 (USD Million)
Table 15.78. Medical Device Regulatory Affairs Outsourcing Market for Class I Devices, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.79. Medical Device Regulatory Affairs Outsourcing Market for Class II Devices, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.80. Medical Device Regulatory Affairs Outsourcing Market for Class III Devices, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.81. Medical Device Regulatory Affairs Outsourcing Market: Distribution by Therapeutic Area, 2019 and 2030 (USD Million)
Table 15.82. Medical Device Regulatory Affairs Outsourcing Market for Cardiovascular Disorders, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.83. Medical Device Regulatory Affairs Outsourcing Market for Central Nervous System Disorders, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.84. Medical Device Regulatory Affairs Outsourcing Market for Metabolic Disorders, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.85. Medical Device Regulatory Affairs Outsourcing Market for Oncological Disorders, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.86. Medical Device Regulatory Affairs Outsourcing Market for Orthopedic Disorders, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.87. Medical Device Regulatory Affairs Outsourcing Market for Ophthalmic Disorders, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.88. Medical Device Regulatory Affairs Outsourcing Market for Pain Disorders, 2019-2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.89. Medical Device Regulatory Affairs Outsourcing Market for Respiratory Disorders, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.90. Medical Device Regulatory Affairs Outsourcing Market for Other Therapeutic Areas, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.91. Medical Device Regulatory Affairs Outsourcing Market for GAP-Analysis in North America, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.92. Medical Device Regulatory Affairs Outsourcing Market for GAP-Analysis in Europe, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.93. Medical Device Regulatory Affairs Outsourcing Market for GAP-Analysis in Asia-Pacific, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.94. Medical Device Regulatory Affairs Outsourcing Market for GAP-Analysis in Rest of the World, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.95. Medical Device Regulatory Affairs Outsourcing Market for Legal Representation in North America, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.96. Medical Device Regulatory Affairs Outsourcing Market for Legal Representation in Europe, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.97. Medical Device Regulatory Affairs Outsourcing Market for Legal Representation in Asia-Pacific, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.98. Medical Device Regulatory Affairs Outsourcing Market for Legal Representation in Rest of the World, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.99. Medical Device Regulatory Affairs Outsourcing Market for Notified Body Selection in North America, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.100. Medical Device Regulatory Affairs Outsourcing Market for Notified Body Selection in Europe, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.101. Medical Device Regulatory Affairs Outsourcing Market for Notified Body Selection in Asia-Pacific, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.102. Medical Device Regulatory Affairs Outsourcing Market for Notified Body Selection in Rest of the World, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.103. Medical Device Regulatory Affairs Outsourcing Market for Product Labeling-Related Services in North America, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.104. Medical Device Regulatory Affairs Outsourcing Market for Product Labeling-Related Services in Europe, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.105. Medical Device Regulatory Affairs Outsourcing Market for Product Labeling-Related Services in Asia-Pacific, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.106. Medical Device Regulatory Affairs Outsourcing Market for Product Labeling-Related Services in Rest of the World, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.107. Medical Device Regulatory Affairs Outsourcing Market for Product Registration and Clinical Trial Applications in North America, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.108. Medical Device Regulatory Affairs Outsourcing Market for Product Registration and Clinical Trial Applications in Europe, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.109. Medical Device Regulatory Affairs Outsourcing Market for Product Registration and Clinical Trial Applications in Asia-Pacific, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.110. Medical Device Regulatory Affairs Outsourcing Market for Product Registration and Clinical Trial Applications in Rest of the World, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.111. Medical Device Regulatory Affairs Outsourcing Market for Regulatory Writing and Publishing in North America, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.112. Medical Device Regulatory Affairs Outsourcing Market for Regulatory Writing and Publishing in Europe, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.113. Medical Device Regulatory Affairs Outsourcing Market for Regulatory Writing and Publishing in Asia-Pacific, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.114. Medical Device Regulatory Affairs Outsourcing Market for Regulatory Writing and Publishing in Rest of the World, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.115. Medical Device Regulatory Affairs Outsourcing Market for Regulatory Document Submissions in North America, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.116. Medical Device Regulatory Affairs Outsourcing Market for Regulatory Document Submissions in Europe, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.117. Medical Device Regulatory Affairs Outsourcing Market for Regulatory Document Submissions in Asia-Pacific, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.118. Medical Device Regulatory Affairs Outsourcing Market for Regulatory Document Submissions in Rest of the World, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.119. Medical Device Regulatory Affairs Outsourcing Market for Risk Management Service in North America, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.120. Medical Device Regulatory Affairs Outsourcing Market for Risk Management Service in Europe, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.121. Medical Device Regulatory Affairs Outsourcing Market for Risk Management Service in Asia-Pacific, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.122. Medical Device Regulatory Affairs Outsourcing Market for Risk Management Service in Rest of the World, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.123. Medical Device Regulatory Affairs Outsourcing Market for Technical Dossier Set-Up in North America, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.124. Medical Device Regulatory Affairs Outsourcing Market for Technical Dossier Set-Up in Europe, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.125. Medical Device Regulatory Affairs Outsourcing Market for Technical Dossier Set-Up in Asia-Pacific, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.126. Medical Device Regulatory Affairs Outsourcing Market for Technical Dossier Set-Up in Rest of the World, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.127. Medical Device Regulatory Affairs Outsourcing Market for Vigilance & Medical Device Report in North America, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.128. Medical Device Regulatory Affairs Outsourcing Market for Vigilance & Medical Device Report in Europe, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.129. Medical Device Regulatory Affairs Outsourcing Market for Vigilance & Medical Device Report in Asia-Pacific, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.130. Medical Device Regulatory Affairs Outsourcing Market for Vigilance & Medical Device Report in Rest of the World, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.131. Medical Device Regulatory Affairs Outsourcing Market for Class I Devices in North America, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.132. Medical Device Regulatory Affairs Outsourcing Market for Class I Devices in Europe, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.133. Medical Device Regulatory Affairs Outsourcing Market for Class I Devices in Asia-Pacific, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.134. Medical Device Regulatory Affairs Outsourcing Market for Class I Devices in Rest of the World, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.135. Medical Device Regulatory Affairs Outsourcing Market for Class II Devices in North America, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.136. Medical Device Regulatory Affairs Outsourcing Market for Class II Devices in Europe, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.137. Medical Device Regulatory Affairs Outsourcing Market for Class II Devices in Asia-Pacific, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.138. Medical Device Regulatory Affairs Outsourcing Market for Class II Devices in Rest of the World, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.139. Medical Device Regulatory Affairs Outsourcing Market for Class III Devices in North America, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.140. Medical Device Regulatory Affairs Outsourcing Market for Class III Devices in Europe, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.141. Medical Device Regulatory Affairs Outsourcing Market for Class III Devices in Asia-Pacific, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.142. Medical Device Regulatory Affairs Outsourcing Market for Class III Devices in Rest of the World, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.143. Medical Device Regulatory Affairs Outsourcing Market for Cardiovascular Disorders in North America, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.144. Medical Device Regulatory Affairs Outsourcing Market for Cardiovascular Disorders in Europe, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.145. Medical Device Regulatory Affairs Outsourcing Market for Cardiovascular Disorders in Asia-Pacific, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.146. Medical Device Regulatory Affairs Outsourcing Market for Cardiovascular Disorders in Rest of the World, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.147. Medical Device Regulatory Affairs Outsourcing Market for Central Nervous System Disorders in North America, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.148. Medical Device Regulatory Affairs Outsourcing Market for Central Nervous System Disorders in Europe, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.149. Medical Device Regulatory Affairs Outsourcing Market for Central Nervous System Disorders in Asia-Pacific, 2019-2030 (USD Million)
Table 15.150. Medical Device Regulatory Affairs Outsourcing Market for Central Nervous System Disorders in Rest of the World, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.151. Medical Device Regulatory Affairs Outsourcing Market for Metabolic Disorders in North America, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.152. Medical Device Regulatory Affairs Outsourcing Market for Metabolic Disorders in Europe, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.153. Medical Device Regulatory Affairs Outsourcing Market for Metabolic Disorders in Asia-Pacific, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.154. Medical Device Regulatory Affairs Outsourcing Market for Metabolic Disorders in Rest of the World, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.155. Medical Device Regulatory Affairs Outsourcing Market for Oncological Disorders in North America, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.156. Medical Device Regulatory Affairs Outsourcing Market for Oncological Disorders in Europe, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.157. Medical Device Regulatory Affairs Outsourcing Market for Oncological Disorders in Asia-Pacific, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.158. Medical Device Regulatory Affairs Outsourcing Market for Oncological Disorders in Rest of the World, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.159. Medical Device Regulatory Affairs Outsourcing Market for Ophthalmological Disorders in North America, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.160. Medical Device Regulatory Affairs Outsourcing Market for Ophthalmological Disorders in Europe, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.161. Medical Device Regulatory Affairs Outsourcing Market for Ophthalmological Disorders in Asia-Pacific, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.162. Medical Device Regulatory Affairs Outsourcing Market for Ophthalmological Disorders in Rest of the World, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.163. Medical Device Regulatory Affairs Outsourcing Market for Orthopedic Disorders in North America, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.164. Medical Device Regulatory Affairs Outsourcing Market for Orthopedic Disorders in Europe, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.165. Medical Device Regulatory Affairs Outsourcing Market for Orthopedic Disorders in Asia-Pacific, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.166. Medical Device Regulatory Affairs Outsourcing Market for Orthopedic Disorders in Rest of the World, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.167. Medical Device Regulatory Affairs Outsourcing Market for Pain Disorders in North America, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.168. Medical Device Regulatory Affairs Outsourcing Market for Pain Disorders in Europe, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.169. Medical Device Regulatory Affairs Outsourcing Market for Pain Disorders in Asia-Pacific, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.170. Medical Device Regulatory Affairs Outsourcing Market for Pain Disorders in Rest of the World, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.171. Medical Device Regulatory Affairs Outsourcing Market for Respiratory Disorders in North America, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.172. Medical Device Regulatory Affairs Outsourcing Market for Respiratory Disorders in Europe, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.173. Medical Device Regulatory Affairs Outsourcing Market for Respiratory Disorders in Asia-Pacific, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.174. Medical Device Regulatory Affairs Outsourcing Market for Respiratory Disorders in Rest of the World, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.175. Medical Device Regulatory Affairs Outsourcing Market for Other Disorders in North America, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.176. Medical Device Regulatory Affairs Outsourcing Market for Other Disorders in Europe, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.177. Medical Device Regulatory Affairs Outsourcing Market for Other Disorders in Asia-Pacific, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.178. Medical Device Regulatory Affairs Outsourcing Market for Other Disorders in Rest of the World, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.179. Medical Device Regulatory Affairs Outsourcing Market: Distribution by Company Size, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.180. Medical Device Regulatory Affairs Outsourcing Market for Small-Sized Companies, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.181. Medical Device Regulatory Affairs Outsourcing Market for Mid-Sized Companies, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.182. Medical Device Regulatory Affairs Outsourcing Market for Large Companies, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.183. Overall Medical Device Regulatory Affairs Outsourcing Market: Comparative Evolution Scenarios, 2019, 2025 and 2030: Conservative, Base and Optimistic Scenarios (USD Million) (USD Million)
Table 15.184. Survey Insights: Distribution of Respondents by Year of Establishment of Company
Table 15.185. Survey Insights: Distribution of Respondents by Employee Size
Table 15.186. Survey Insights: Distribution of Respondents by Location of Company Headquarters (Continent-Wise)
Table 15.187. Survey Insights: Distribution of Respondents by Location of Company Headquarters (Country-Wise)
Table 15.188. Survey Insights: Distribution by Designation and Seniority Level
Table 15.189. Survey Insights: Distribution by Types of Services
Table 15.190. Survey Insights: Distribution by Market Access
Table 15.191. Survey Insights: Distribution by Type and Size of Clientele
Table 15.192. Survey Insights: Distribution by Number of Projects
Table 15.193. Survey Insights: Distribution by Proportion of Clients Outsourcing Regulatory Affairs-Related Services
Table 15.194. Survey Insights: Distribution by Current and Future Market Opportunity

Listed Companies

The following companies / institutes / government bodies and organizations have been mentioned in this report.

  1. 1MED SA
  2. 4Clinics
  3. A+ Science
  4. Abbott
  5. ABIOGENESIS CLINPHARM
  6. ABX-CRO
  7. Accell Clinical Research
  8. Accredited Consultants 
  9. Accutest Global
  10. Acorn Regulatory Consultancy Services
  11. Acrapack
  12. acromion
  13. aCROss Medical
  14. Activa Cro
  15. Actolis
  16. ADAX International
  17. Advanced Medical Research (AMR)
  18. Advena
  19. AE Performance Testing Lab 
  20. Affinity Bio Partners
  21. Afra Pharma Consultant
  22. AG Mednet
  23. Aginko Research 
  24. AICROS
  25. Al Tamimi
  26. Allied Clinical Management
  27. Allscripts Healthcare Solutions
  28. Alquest
  29. ALTIORA 
  30. Amarex
  31. American Preclinical Services
  32. AmeRuss 
  33. Amritt 
  34. analyze & realize
  35. Andaman Medical
  36. Anteris Medical
  37. ANTRIX
  38. A-pharmaconsult
  39. apices
  40. APO Plus Station
  41. Appletree CI Group
  42. Arazy Group Consultants
  43. ARC Pharma 
  44. Archemin
  45. Arlenda
  46. ARQon
  47. Asia Actual
  48. ATLANSTAT
  49. AtoZ-CRO
  50. Australian Healthcare Solutions
  51. Auxilife Scientific Services
  52. AVANTI
  53. AVIAD Life Sciences
  54. Axonal-Biostatem
  55. Azelix
  56. Barons Medical Consulting
  57. Beaufort
  58. Becton Dickinson
  59. Beijing JRJ Science and technology
  60. BIC Group
  61. BioAgile Therapeutics
  62. BIOCODEX Nordics 
  63. BioFortis
  64. Biomapas
  65. Biomedical Regulatory Consulting
  66. Biomedical Strategy 
  67. BioMotiv
  68. BioPlan
  69. Biorasi
  70. Bioreg Services
  71. Bioscience
  72. Biotech Regulatory Solutions
  73. BioTeknica 
  74. BiTrial Clinical Research
  75. BLAU Pharmaceutical Service
  76. Boston Biomedical Associates (BBA)
  77. Boston MedTech Advisors 
  78. Boston Scientific
  79. Brandwood CKC
  80. Bridge Pharm
  81. BSI
  82. Cactus Global
  83. Cardinal Health
  84. CardioMed Device Consultants 
  85. Cardiovascular European Research Center (CERC)
  86. CARSL Consulting 
  87. Catawba Research
  88. Cato Research (CATO)
  89. CC Clinical research Consultants
  90. Ceetox
  91. C'en Al Research
  92. CERES
  93. CHA Medical Group
  94. Charles River Laboratories
  95. ChemADVISOR
  96. Chemical Inspection and Regulation Service (CIRS)
  97. China Med Device
  98. Chris Freer Associates 
  99. Clarivate Analytics 
  100. ClinAudits
  101. ClinDatrix
  102. Clinical Device Group
  103. Clinical Research & Compliance Consulting
  104. Clinical Trial Data Services
  105. CliniExperts
  106. Clinilabs
  107. Clinipace 
  108. Clinlogix
  109. Clinmark
  110. ClinMed Pharma
  111. ClinSync
  112. Clintec
  113. CMIC Group
  114. CMX Research
  115. Cobridge
  116. Commercial Eyes
  117. ComplianceAcuity
  118. Complya Consulting
  119. CONET
  120. Consultys Switzerland
  121. Convex
  122. Costello Medical 
  123. Courante Oncology
  124. CPS Cortex
  125. Creganna Medical
  126. Criterium
  127. Cromos Pharma
  128. CROMSOURCE
  129. CROs NT
  130. Crown CRO
  131. CSSi LifeSciences
  132. CTI
  133. CTNT
  134. CurAccel
  135. CW Research & Management
  136. CYA Medical Device Consulting
  137. Dalia Givony, Regulatory & Clinical Consulting
  138. Databean
  139. Datapharm Australia
  140. Datavant
  141. Datavant 
  142. De Groot Technical Services
  143. DEKRA
  144. devicia
  145. DH RegSys
  146. dicentra
  147. DiscGenics
  148. DKSH Marketing Services Spain
  149. dMed
  150. Donawa Lifescience Consulting
  151. Dor Pharmaceutical Services
  152. DP Clinical
  153. DSA Consultants
  154. DuPage Medical Group
  155. EAS Consulting Group
  156. EG Mont Brazil
  157. Eli Lily 
  158. Emergo
  159. Engel, Hellyer & Partners 
  160. EPIC Research
  161. Essilor
  162. ESTERN Medical
  163. Ethicare 
  164. EuDRAcon 
  165. Eurofins Scientific
  166. Eurotrials
  167. Evidilya
  168. Exalon 
  169. ExecuPharm
  170. Factory CRO
  171. FDAInsight
  172. Fermish Clinical Technologies
  173. FGK Clinical Research
  174. FMD K&L
  175. Focal Point Research
  176. Fountain Medical Development (FMD)
  177. Fresenius Medical Care
  178. Freyr
  179. GCP-Service International
  180. GE Healthcare
  181. genae
  182. Genco Medical
  183. Genelife Clinical Research
  184. Genpact
  185. George Clinical
  186. Getz Healthcare
  187. GKM
  188. Global Pharma Tek
  189. Global Regulatory Affairs (GRA)
  190. Global Regulatory Partners
  191. Global Regulatory Services
  192. Green Building Japan (GBJ) 
  193. Grove Group
  194. Gsap
  195. Gulf Medical Devices Consultancy 
  196. Health Advances
  197. Health Sciences 
  198. Healthcare International Partners
  199. HealthLink
  200. HingeClinica
  201. HungaroTrial
  202. I 3 CONSULTING 
  203. ICBio 
  204. ICON
  205. ICRC-Weyer
  206. ICTA
  207. idcOnic
  208. Illingworth Research Group
  209. INE G-MED (through G-MED North America)
  210. Innomar Strategies (a part of AmerisourceBergen)
  211. Inrextest
  212. Integrated Resources CRO Division
  213. Intel 
  214. International HealthCare (IHC)
  215. Intertek Group
  216. Ipsum
  217. IQVIA
  218. Iris Pharma
  219. Ironstone Product Development
  220. IRW
  221. ISA HEALTH
  222. ITEC Services
  223. IVDeology
  224. IZiel Healthcare
  225. J Knipper
  226. Japan MDC (JMDC)
  227. Johnson & Johnson
  228. JSS Medical Research
  229. KCR
  230. KCRI
  231. KD&A
  232. Ken Block Consulting
  233. Kensington Swan 
  234. Keystone Regulatory Services
  235. Kiana Systems
  236. Kinapse
  237. KLIFO
  238. Knoell
  239. Kobridge Consulting
  240. KPS Clinical Services
  241. L.S Marketing & Registration
  242. LabCorp
  243. Lambda Therapeutic Research 
  244. Larix
  245. Lean RAQA
  246. Leon Research
  247. Li-Med RA & QA Experts
  248. Linical
  249. LINK Medical
  250. LIONBRIDGE
  251. LNAge
  252. MakroCare
  253. Malca Chen-Zion Group
  254. MANDALA International
  255. Mapi Group
  256. MasterControl
  257. MAXIS
  258. McCarthy Consultant Services
  259. McGee Pharma International (MPI)
  260. McMillan Research
  261. MD101 Consulting
  262. MD-Clinicals
  263. mdi Consultants
  264. mdi Europa
  265. MDP Solutions
  266. MED Institute
  267. Medelis
  268. Medfiles Group
  269. Medical Equipment Compliance Association
  270. Medidee
  271. MeDiNova Research
  272. MediqTrans
  273. Meditrial
  274. MEDITRIAL
  275. Meditrial Europe
  276. MedNet
  277. Medpace
  278. MedPass International
  279. MedQ Consultants
  280. Medtronic 
  281. Medvance
  282. Meiji Pharmaceutical University (MPU)
  283. Mene Research
  284. Mericon 
  285. Meshayu Consultants
  286. MethodSense
  287. Metrics Research
  288. MIC Medical
  289. Micren Healthcare
  290. Microsoft
  291. Mid-Link Consulting
  292. Mn Solutions
  293. Mobius Medical 
  294. MolecularMD
  295. Morley Research Consortium
  296. Morula HealthTech
  297. Musculoskeletal Clinical Regulatory Advisers (MCRA)
  298. NAGLREITER
  299. NAMSA
  300. Navitas Life Sciences
  301. NCGS
  302. NEOMED Services
  303. Neopharm
  304. Neox Clinical Research
  305. Neozene
  306. Nerac
  307. New England Research Institutes (NERI)
  308. NHP Consulting
  309. Nordic Health Economics AB (NHE)
  310. Northlane Capital Partners
  311. Northside consulting
  312. Novartis
  313. NovaTrials
  314. Novem Healthcare
  315. Novotek
  316. Novum
  317. NSF International
  318. Nyprax Pharma
  319. O4 Research
  320. Obelis Group
  321. OmniComm Systems
  322. Onorach
  323. Operon Strategist
  324. OPIS
  325. Ora
  326. Osmunda
  327. Pace Analytical
  328. Pacific Bridge Medical
  329. Pacific Clinical Research Group (PCRG) 
  330. Parexel
  331. PAREXEL Biotech
  332. Paxmed Interational
  333. Pearl Pathways
  334. Pepgra
  335. Perfect Pharmaceuticals Consultants 
  336. Perfection-CRO
  337. Pharma to Market
  338. Pharmaceutical Regulatory Services 
  339. Pharmaceutical Solutions
  340. Pharmaco-Kinesis
  341. Pharmahungary Group
  342. PharmaLex
  343. PharmaMed Global (through AJW Technology Consultants)
  344. PharmaMed Research
  345. PharmDedict 
  346. PharmEng Regulatory Affairs
  347. PharmOut
  348. Phidea Group
  349. Pivotal
  350. PPD
  351. PQE Group
  352. PRA International
  353. Practice Fusion
  354. PRC Clinical
  355. Precision Medicine Group
  356. Premier Research
  357. Professional Regulatory Affairs
  358. Profil 
  359. Promedica International
  360. ProMedoss
  361. ProPharma Group
  362. Prosoft Clinical
  363. ProTrials
  364. Proxima Clinical Research
  365. Pharmaceutical and Regulatory Services (PRSG)
  366. Q&R Canada
  367. QA Consulting
  368. QAdvis
  369. Qmed Consulting
  370. Qserve Group
  371. QST Consultations
  372. Q-Trials
  373. Qualitiso
  374. Qualtech Consulting
  375. Quanticate
  376. Quantum Solutions India 
  377. Quantum Solutions India (QSI) 
  378. QUNIQUE 
  379. R & C Consulting Group
  380. R&G PharmaStudies
  381. R&Q
  382. RAMED
  383. RCQ Solutions
  384. RCRI
  385. ReadyClinical 
  386. Reg-Affairs & QualiPractixis
  387. RegDesk
  388. Registrar Corp
  389. Regulatory Compliance Associates
  390. Regulatory Insight
  391. Regulatory Professionals
  392. Reimbursement Strategies
  393. Research Professionals
  394. RGL Research
  395. Rho
  396. Rook Quality Systems
  397. RQMIS
  398. RQSolutions
  399. RTI Health Solutions 
  400. Safis Solutions
  401. Samsung Medical Center
  402. Saudi Telecom Company (STC) 
  403. Scandinavian CRO
  404. Scandinavian Regulatory Services (SRS)
  405. Scope International
  406. SeerPharma
  407. Sentez CRO
  408. Seoul CRO
  409. SEQ
  410. SGS
  411. Shanghai QiSheng Business Consulting
  412. SHYFT Analytics 
  413. Sidley Austin
  414. Siemens
  415. Simmons & Simmons
  416. Sipra Labs
  417. Sixmurs Group
  418. Society for Clinical Research Sites 
  419. Southern Star Research
  420. SPARTA
  421. SPharm
  422. StarFish Medical
  423. STATKING Clinical Services 
  424. SteriPack Group
  425. SterlingBio
  426. Strategic Compliance International
  427. StrugoPharm
  428. Stryker
  429. Sumika Chemical Analysis Service (SCAS)
  430. SunFlare
  431. Symbioteq 
  432. Syneos Health
  433. Syntax
  434. Synteract
  435. TAB Clinical
  436. TCA Clinical Research
  437. TechnoSTAT
  438. Telecommunications Industry Association (TIA) 
  439. The CLINICAL TRIAL Company Group
  440. The CRO Group
  441. The Integra Group
  442. The Society for Clinical Research Sites (SCRS)
  443. The Weinberg Group
  444. Thema Med
  445. Theo Manufacturing 
  446. TheraGenesis
  447. TPIreg
  448. TRAC
  449. TransPerfect Life Sciences
  450. Trial Form Support International (TFS) (Acquired by Ratos)
  451. Turacoz Healthcare Solutions
  452. TÜV SÜD-Healthcare & Medical Devices
  453. UBC
  454. Ulmer Ventures
  455. Underwriters Laboratory (UL)
  456. Unikal Consultants
  457. Vantage BioTrials
  458. Vantage Consulting International
  459. Venn Life Sciences
  460. Veristat
  461. VOLER Biotech Consulting
  462. Volv
  463. Vyomus Consulting
  464. WCCT Global
  465. Wipro
  466. Wonderville
  467. WOODLEY BIOREG
  468. Wuxi AppTec
  469. Zeincro
  470. Zi-Medical
  471. Zimmer Biomet
  472. Zwiers Regulatory Consulting

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