Contract Regulatory Affairs Management Market for Medical Devices, 2019-2030

Report
551 Pages
November 2019
Region: Global
Roots Analysis
ID: 4895381

Overview

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 January 2018, 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, and popular therapeutic area(s).
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 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.

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 Area of Specialization
6.2.5. Analysis by Type of Regulatory Affairs-Related Service Offered
6.2.6. Analysis by Type of Additional Services Offered
6.2.7. Analysis by Device Class
6.2.8. Analysis by Type of Clientele
6.2.9. Analysis by Medical Device Regulatory Compliance Authorities
6.2.10. Analysis by Region of Operation
6.2.11. Analysis by Popular Therapeutic Areas
6.3. Concluding Remarks

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. Service Portfolio
7.2.4.3. 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. PharmaLex
7.3.3.1. Company Overview
7.3.3.2. Service Portfolio
7.3.3.3 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

8 BENCHMARK ANALYSIS

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

10 MEDICAL DEVICE DEVELOPER AND CRO RELATIONSHIPS: KEY VALUE DRIVERS AND 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 Labelling-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 Technical Dossier Set-Up, 2019-2030
11.5.9. 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 Labelling-Related Services in North America, 2019-2030
11.8.14. Medical Device Regulatory Affairs Outsourcing Market for Product Labelling-Related Services in Europe, 2019-2030
11.8.15. Medical Device Regulatory Affairs Outsourcing Market for Product Labelling-Related Services in Asia-Pacific, 2019-2030
11.8.16. Medical Device Regulatory Affairs Outsourcing Market for Product Labelling-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 Technical Dossier Set-Up in North America, 2019-2030
11.8.30. Medical Device Regulatory Affairs Outsourcing Market for Technical Dossier Set-Up in Europe, 2019-2030
11.8.31. Medical Device Regulatory Affairs Outsourcing Market for Technical Dossier Set-Up in Asia-Pacific, 2019-2030
11.8.32. Medical Device Regulatory Affairs Outsourcing Market for Technical Dossier Set-Up in Rest of the World, 2019-2030
11.8.33. Medical Device Regulatory Affairs Outsourcing Market for Vigilance & Medical Device Report in North America, 2019-2030
11.8.34. Medical Device Regulatory Affairs Outsourcing Market for Vigilance & Medical Device Report in Europe, 2019-2030
11.8.35. Medical Device Regulatory Affairs Outsourcing Market for Vigilance & Medical Device Report in Asia-Pacific, 2019-2030
11.8.36. 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

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 Region of Operation
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 DATA16 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 Devices Regulatory Affairs CROs: Distribution by Type of Regulatory Affairs-Related Services Offered
Figure 6.6. Medical Devices Regulatory Affairs CROs: Distribution by Year of Establishment, Geography and Type of Regulatory Affairs-Related Services Offered
Figure 6.7. Medical Devices Regulatory Affairs CROs: Distribution by Type of Additional Services Offered
Figure 6.8. Medical Devices Regulatory Affairs CROs: Distribution by Device Class
Figure 6.9. Medical Devices Regulatory Affairs CROs: Distribution by Type and Size of Clientele
Figure 6.10. Medical Devices Regulatory Affairs CROs: Distribution by Medical Device Regulatory Compliance Authorities
Figure 6.11. Medical Devices Regulatory Affairs CROs: Distribution by Region of Operation (Region-wise)
Figure 6.12. Medical Devices Regulatory Affairs CROs: Distribution by Region of Operation (Country-wise)
Figure 6.13. Medical Devices Regulatory Affairs CROs: Popular Therapeutic Areas
Figure 7.1. CTI: Service Portfolio
Figure 7.2. Medpace: Annual Revenues, 2014-2018 (USD Million)
Figure 7.3. Medpace: Service Portfolio
Figure 7.4. NAMSA: Service Portfolio
Figure 7.5. PAREXEL: Service Portfolio
Figure 7.6. PAREXEL: Annual Revenues, 2014-2017 (USD Million)
Figure 7.7. Premier Research: Service Portfolio
Figure 7.8. Underwriters Laboratory (UL): Service Portfolio
Figure 7.8. CROMSOURCE: Service Portfolio
Figure 7.9. ICON: Annual Revenues, 2014-H1 2019 (USD Million)
Figure 7.10. ICON: Service Portfolio
Figure 7.11. PharmaLex: Service Portfolio
Figure 7.12. SteriPack: Service Portfolio
Figure 7.13. MIC Medical: Service Portfolio
Figure 8.1. Benchmark Analysis: Distribution by Region and Size of Employee Base
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: North America, 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 Labelling-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 Technical Dossier Set-Up, 2019-2030 (USD Million)
Figure 11.28. Medical Device Regulatory Affairs Outsourcing Market for Vigilance & Medical Device Report, 2019-2030 (USD Million)
Figure 11.29. Medical Device Regulatory Affairs Outsourcing Market: Distribution by Device Class, 2019 and 2030 (USD Million)
Figure 11.30. Medical Device Regulatory Affairs Outsourcing Market for Class I Devices, 2019-2030 (USD Million)
Figure 11.31. Medical Device Regulatory Affairs Outsourcing Market for Class II Devices, 2019-2030 (USD Million)
Figure 11.32. Medical Device Regulatory Affairs Outsourcing Market for Class III Devices, 2019-2030 (USD Million)
Figure 11.33. Medical Device Regulatory Affairs Outsourcing Market: Distribution by Therapeutic Area, 2019 and 2030 (USD Million)
Figure 11.34. Medical Device Regulatory Affairs Outsourcing Market for Cardiovascular Disorders, 2019-2030 (USD Million)
Figure 11.35. Medical Device Regulatory Affairs Outsourcing Market for Central Nervous System Disorders, 2019-2030 (USD Million)
Figure 11.36. Medical Device Regulatory Affairs Outsourcing Market for Metabolic Disorders, 2019-2030 (USD Million)
Figure 11.37. Medical Device Regulatory Affairs Outsourcing Market for Oncological Disorders, 2019-2030 (USD Million)
Figure 11.38. Medical Device Regulatory Affairs Outsourcing Market for Orthopedic Disorders, 2019-2030 (USD Million)
Figure 11.39. Medical Device Regulatory Affairs Outsourcing Market for Ophthalmic Disorders, 2019-2030 (USD Million)
Figure 11.40. Medical Device Regulatory Affairs Outsourcing Market for Pain Disorders, 2019-2030 (USD Million)
Figure 11.41. Medical Device Regulatory Affairs Outsourcing Market for Respiratory Disorders, 2019-2030 (USD Million)
Figure 11.42. Medical Device Regulatory Affairs Outsourcing Market for Other Therapeutic Areas, 2019-2030 (USD Million)
Figure 11.43. Medical Device Regulatory Affairs Outsourcing Market for GAP-Analysis in North America, 2019-2030 (USD Million)
Figure 11.44. Medical Device Regulatory Affairs Outsourcing Market for GAP-Analysis in Europe, 2019-2030 (USD Million)
Figure 11.45. Medical Device Regulatory Affairs Outsourcing Market for GAP-Analysis in Asia-Pacific, 2019-2030 (USD Million)
Figure 11.46. Medical Device Regulatory Affairs Outsourcing Market for GAP-Analysis in Rest of the World, 2019-2030 (USD Million)
Figure 11.47. Medical Device Regulatory Affairs Outsourcing Market for Legal Representation in North America, 2019-2030 (USD Million)
Figure 11.48. Medical Device Regulatory Affairs Outsourcing Market for Legal Representation in Europe, 2019-2030 (USD Million)
Figure 11.49. Medical Device Regulatory Affairs Outsourcing Market for Legal Representation in Asia-Pacific, 2019-2030 (USD Million)
Figure 11.50. Medical Device Regulatory Affairs Outsourcing Market for Legal Representation in Rest of the World, 2019-2030 (USD Million)
Figure 11.51. Medical Device Regulatory Affairs Outsourcing Market for Notified Body Selection in North America, 2019-2030 (USD Million)
Figure 11.52. Medical Device Regulatory Affairs Outsourcing Market for Notified Body Selection in Europe, 2019-2030 (USD Million)
Figure 11.53. Medical Device Regulatory Affairs Outsourcing Market for Notified Body Selection in Asia-Pacific, 2019-2030 (USD Million)
Figure 11.54. Medical Device Regulatory Affairs Outsourcing Market for Notified Body Selection in Rest of the World, 2019-2030 (USD Million)
Figure 11.55. Medical Device Regulatory Affairs Outsourcing Market for Product Labelling-Related Services in North America, 2019-2030 (USD Million)
Figure 11.56. Medical Device Regulatory Affairs Outsourcing Market for Product Labelling-Related Services in Europe, 2019-2030 (USD Million)
Figure 11.57. Medical Device Regulatory Affairs Outsourcing Market for Product Labelling-Related Services in Asia-Pacific, 2019-2030 (USD Million)
Figure 11.58. Medical Device Regulatory Affairs Outsourcing Market for Product Labelling-Related Services in Rest of the World, 2019-2030 (USD Million)
Figure 11.59. Medical Device Regulatory Affairs Outsourcing Market for Product Registration and Clinical Trial Applications in North America, 2019-2030 (USD Million)
Figure 11.60. Medical Device Regulatory Affairs Outsourcing Market for Product Registration and Clinical Trial Applications in Europe, 2019-2030 (USD Million)
Figure 11.61. Medical Device Regulatory Affairs Outsourcing Market for Product Registration and Clinical Trial Applications in Asia-Pacific, 2019-2030 (USD Million)
Figure 11.62. Medical Device Regulatory Affairs Outsourcing Market for Product Registration and Clinical Trial Applications in Rest of the World, 2019-2030 (USD Million)
Figure 11.63. Medical Device Regulatory Affairs Outsourcing Market for Regulatory Writing and Publishing in North America, 2019-2030 (USD Million)
Figure 11.64. Medical Device Regulatory Affairs Outsourcing Market for Regulatory Writing and Publishing in Europe, 2019-2030 (USD Million)
Figure 11.65. Medical Device Regulatory Affairs Outsourcing Market for Regulatory Writing and Publishing in Asia-Pacific, 2019-2030 (USD Million)
Figure 11.66. Medical Device Regulatory Affairs Outsourcing Market for Regulatory Writing and Publishing in Rest of the World, 2019-2030 (USD Million)
Figure 11.67. Medical Device Regulatory Affairs Outsourcing Market for Regulatory Document Submissions in North America, 2019-2030 (USD Million)
Figure 11.68. Medical Device Regulatory Affairs Outsourcing Market for Regulatory Document Submissions in Europe, 2019-2030 (USD Million)
Figure 11.69. Medical Device Regulatory Affairs Outsourcing Market for Regulatory Document Submissions in Asia-Pacific, 2019-2030 (USD Million)
Figure 11.70. Medical Device Regulatory Affairs Outsourcing Market for Regulatory Document Submissions in Rest of the World, 2019-2030 (USD Million)
Figure 11.71. Medical Device Regulatory Affairs Outsourcing Market for Technical Dossier Set-Up in North America, 2019-2030 (USD Million)
Figure 11.72. Medical Device Regulatory Affairs Outsourcing Market for Technical Dossier Set-Up in Europe, 2019-2030 (USD Million)
Figure 11.73. Medical Device Regulatory Affairs Outsourcing Market for Technical Dossier Set-Up in Asia-Pacific, 2019-2030 (USD Million)
Figure 11.74. Medical Device Regulatory Affairs Outsourcing Market for Technical Dossier Set-Up in Rest of the World, 2019-2030 (USD Million)
Figure 11.75. Medical Device Regulatory Affairs Outsourcing Market for Vigilance & Medical Device Report in North America, 2019-2030 (USD Million)
Figure 11.76. Medical Device Regulatory Affairs Outsourcing Market for Vigilance & Medical Device Report in Europe, 2019-2030 (USD Million)
Figure 11.77. Medical Device Regulatory Affairs Outsourcing Market for Vigilance & Medical Device Report in Asia-Pacific, 2019-2030 (USD Million)
Figure 11.78. Medical Device Regulatory Affairs Outsourcing Market for Vigilance & Medical Device Report in Rest of the World, 2019-2030 (USD Million)
Figure 11.79. Medical Device Regulatory Affairs Outsourcing Market for Class I Devices in North America, 2019-2030 (USD Million)
Figure 11.80. Medical Device Regulatory Affairs Outsourcing Market for Class I Devices in Europe, 2019-2030 (USD Million)
Figure 11.81. Medical Device Regulatory Affairs Outsourcing Market for Class I Devices in Asia-Pacific, 2019-2030 (USD Million)
Figure 11.82. Medical Device Regulatory Affairs Outsourcing Market for Class I Devices in Rest of the World, 2019-2030 (USD Million)
Figure 11.83. Medical Device Regulatory Affairs Outsourcing Market for Class II Devices in North America, 2019-2030 (USD Million)
Figure 11.84. Medical Device Regulatory Affairs Outsourcing Market for Class II Devices in Europe, 2019-2030 (USD Million)
Figure 11.85. Medical Device Regulatory Affairs Outsourcing Market for Class II Devices in Asia-Pacific, 2019-2030 (USD Million)
Figure 11.86. Medical Device Regulatory Affairs Outsourcing Market for Class II Devices in Rest of the World, 2019-2030 (USD Million)
Figure 11.87. Medical Device Regulatory Affairs Outsourcing Market for Class III Devices in North America, 2019-2030 (USD Million)
Figure 11.88. Medical Device Regulatory Affairs Outsourcing Market for Class III Devices in Europe, 2019-2030 (USD Million)
Figure 11.89. Medical Device Regulatory Affairs Outsourcing Market for Class III Devices in Asia-Pacific, 2019-2030 (USD Million)
Figure 11.90. Medical Device Regulatory Affairs Outsourcing Market for Class III Devices in Rest of the World, 2019-2030 (USD Million)
Figure 11.91. Medical Device Regulatory Affairs Outsourcing Market for Cardiovascular Disorders in North America, 2019-2030 (USD Million)
Figure 11.92. Medical Device Regulatory Affairs Outsourcing Market for Cardiovascular Disorders in Europe, 2019-2030 (USD Million)
Figure 11.93. Medical Device Regulatory Affairs Outsourcing Market for Cardiovascular Disorders in Asia-Pacific, 2019-2030 (USD Million)
Figure 11.94. Medical Device Regulatory Affairs Outsourcing Market for Cardiovascular Disorders in Rest of the World, 2019-2030 (USD Million)
Figure 11.95. Medical Device Regulatory Affairs Outsourcing Market for Central Nervous System Disorders in North America, 2019-2030 (USD Million)
Figure 11.96. Medical Device Regulatory Affairs Outsourcing Market for Central Nervous System Disorders in Europe, 2019-2030 (USD Million)
Figure 11.97. Medical Device Regulatory Affairs Outsourcing Market for Central Nervous System Disorders in Asia-Pacific, 2019-2030 (USD Million)
Figure 11.98. Medical Device Regulatory Affairs Outsourcing Market for Central Nervous System Disorders in Rest of the World, 2019-2030 (USD Million)
Figure 11.99. Medical Device Regulatory Affairs Outsourcing Market for Metabolic Disorders in North America, 2019-2030 (USD Million)
Figure 11.100. Medical Device Regulatory Affairs Outsourcing Market for Metabolic Disorders in Europe, 2019-2030 (USD Million)
Figure 11.101. Medical Device Regulatory Affairs Outsourcing Market for Metabolic Disorders in Asia-Pacific, 2019-2030 (USD Million)
Figure 11.102. Medical Device Regulatory Affairs Outsourcing Market for Metabolic Disorders in Rest of the World, 2019-2030 (USD Million)
Figure 11.103. Medical Device Regulatory Affairs Outsourcing Market for Oncological Disorders in North America, 2019-2030 (USD Million)
Figure 11.104. Medical Device Regulatory Affairs Outsourcing Market for Oncological Disorders in Europe, 2019-2030 (USD Million)
Figure 11.105. Medical Device Regulatory Affairs Outsourcing Market for Oncological Disorders in Asia-Pacific, 2019-2030 (USD Million)
Figure 11.106. Medical Device Regulatory Affairs Outsourcing Market for Oncological Disorders in Rest of the World, 2019-2030 (USD Million)
Figure 11.107. Medical Device Regulatory Affairs Outsourcing Market for Ophthalmological Disorders in North America, 2019-2030 (USD Million)
Figure 11.108. Medical Device Regulatory Affairs Outsourcing Market for Ophthalmological Disorders in Europe, 2019-2030 (USD Million)
Figure 11.109. Medical Device Regulatory Affairs Outsourcing Market for Ophthalmological Disorders in Asia-Pacific, 2019-2030 (USD Million)
Figure 11.100. Medical Device Regulatory Affairs Outsourcing Market for Ophthalmological Disorders in Rest of the World, 2019-2030 (USD Million)
Figure 11.111. Medical Device Regulatory Affairs Outsourcing Market for Orthopedic Disorders in North America, 2019-2030 (USD Million)
Figure 11.112. Medical Device Regulatory Affairs Outsourcing Market for Orthopedic Disorders in Europe, 2019-2030 (USD Million)
Figure 11.113. Medical Device Regulatory Affairs Outsourcing Market for Orthopedic Disorders in Asia-Pacific, 2019-2030 (USD Million)
Figure 11.114. Medical Device Regulatory Affairs Outsourcing Market for Orthopedic Disorders in Rest of the World, 2019-2030 (USD Million)
Figure 11.115. Medical Device Regulatory Affairs Outsourcing Market for Pain Disorders in North America, 2019-2030 (USD Million)
Figure 11.116. Medical Device Regulatory Affairs Outsourcing Market for Pain Disorders in Europe, 2019-2030 (USD Million)
Figure 11.117. Medical Device Regulatory Affairs Outsourcing Market for Pain Disorders in Asia-Pacific, 2019-2030 (USD Million)
Figure 11.118. Medical Device Regulatory Affairs Outsourcing Market for Pain Disorders in Rest of the World, 2019-2030 (USD Million)
Figure 11.119. Medical Device Regulatory Affairs Outsourcing Market for Respiratory Disorders in North America, 2019-2030 (USD Million)
Figure 11.120. Medical Device Regulatory Affairs Outsourcing Market for Respiratory Disorders in Europe, 2019-2030 (USD Million)
Figure 11.121. Medical Device Regulatory Affairs Outsourcing Market for Respiratory Disorders in Asia-Pacific, 2019-2030 (USD Million)
Figure 11.122. Medical Device Regulatory Affairs Outsourcing Market for Respiratory Disorders in Rest of the World, 2019-2030 (USD Million)
Figure 11.123. Medical Device Regulatory Affairs Outsourcing Market for Other Disorders in North America, 2019-2030 (USD Million)
Figure 11.124. Medical Device Regulatory Affairs Outsourcing Market for Other Disorders in Europe, 2019-2030 (USD Million)
Figure 11.125. Medical Device Regulatory Affairs Outsourcing Market for Other Disorders in Asia-Pacific, 2019-2030 (USD Million)
Figure 11.126. Medical Device Regulatory Affairs Outsourcing Market for Other Disorders in Rest of the World, 2019-2030 (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 Region of Operation
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: Medsafe
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 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 Region of Operation
Table 6.9. Medical Devices Regulatory Affairs CROs: Information on Popular Therapeutic Areas
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 7.12. CROMSOURCE: Company Snapshot
Table 7.13. CROMSOURCE: Recent Developments and Future Outlook
Table 7.14. ICON: Company Snapshot
Table 7.15. ICON: Recent Developments and Future Outlook
Table 7.16. PharmaLex: Company Snapshot
Table 7.17. PharmaLex: Recent Developments and Future Outlook
Table 7.18. SteriPack: Company Snapshot
Table 7.19. SteriPack: Recent Developments and Future Outlook
Table 7.20. 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: Region of Operation
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 Devices Regulatory Affairs CROs: Distribution by Type of Regulatory Affairs-Related Services Offered
Table 15.21. Medical Devices Regulatory Affairs CROs: Distribution by Year of Establishment, Geography and Type of Regulatory Affairs-Related Services Offered
Table 15.22. Medical Devices Regulatory Affairs CROs: Distribution by Type of Additional Services Offered
Table 15.23. Medical Devices Regulatory Affairs CROs: Distribution by Device Class
Table 15.24. Medical Devices Regulatory Affairs CROs: Distribution by Type and Size of Clientele
Table 15.25. Medical Devices Regulatory Affairs CROs: Distribution by Medical Device Regulatory Compliance Authorities
Table 15.26. Medical Devices Regulatory Affairs CROs: Distribution by Region of Operation (Region-wise)
Table 15.27. Medical Devices Regulatory Affairs CROs: Distribution by Region of Operation (Country-wise)
Table 15.28. Medical Devices Regulatory Affairs CROs: Distribution by Popular Therapeutic Areas
Table 15.29. Medpace: Annual Revenues, 2014-2018 (USD Million)
Table 15.30. PAREXEL: Annual Revenues, 2014-2017 (USD Million)
Table 15.31. Benchmark Analysis: Distribution by Region and Size of Employee Base
Table 15.32. Benchmark Analysis: North America, Peer Group I
Table 15.33. Benchmark Analysis: North America, Peer Group II
Table 15.34. Benchmark Analysis: North America, Peer Group III
Table 15.35. Benchmark Analysis: North America, Peer Group IV
Table 15.36. Benchmark Analysis: Europe, Peer Group V
Table 15.37. Benchmark Analysis: Europe, Peer Group VI
Table 15.38. Benchmark Analysis: Europe, Peer Group VII
Table 15.39. Benchmark Analysis: Europe, Peer Group VIII
Table 15.40. Benchmark Analysis: Asia Pacific and Rest of the World, Peer Group IX
Table 15.41. Benchmark Analysis: Asia Pacific and Rest of the World, Peer Group X
Table 15.42. Benchmark Analysis: Asia Pacific and Rest of the World, Peer Group XI
Table 15.43. Benchmark Analysis: Asia Pacific and Rest of the World, Peer Group XII
Table 15.44. Benchmark Analysis: Comparison across Peer Groups
Table 15.45. Overall Medical Device Regulatory Affairs Outsourcing Market, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.46. Medical Device Regulatory Affairs Outsourcing Market, 2019 and 2030: Distribution by Geography (USD Million)
Table 15.47. Medical Device Regulatory Affairs Outsourcing Market in North America, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.48. Medical Device Regulatory Affairs Outsourcing Market in the US, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.49. Medical Device Regulatory Affairs Outsourcing Market in Rest of North America, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.50. Medical Device Regulatory Affairs Outsourcing Market in Europe, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.51. Medical Device Regulatory Affairs Outsourcing Market in Italy, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.52. Medical Device Regulatory Affairs Outsourcing Market in Germany, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.53. Medical Device Regulatory Affairs Outsourcing Market in France, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.54. Medical Device Regulatory Affairs Outsourcing Market in Spain, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.55. Medical Device Regulatory Affairs Outsourcing Market in the UK, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.56. Medical Device Regulatory Affairs Outsourcing Market in Rest of Europe, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.57. Medical Device Regulatory Affairs Outsourcing Market in Asia-Pacific, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.58. Medical Device Regulatory Affairs Outsourcing Market in China, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.59. Medical Device Regulatory Affairs Outsourcing Market in Japan, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.60. Medical Device Regulatory Affairs Outsourcing Market in India, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.61. Medical Device Regulatory Affairs Outsourcing Market in Rest of the Asia-Pacific, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.62. Medical Device Regulatory Affairs Outsourcing Market in Rest of the World, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.63. Medical Device Regulatory Affairs Outsourcing Market, 2019 and 2030: Distribution by Type of Regulatory Affairs-Related Service (USD Million)
Table 15.64. Medical Device Regulatory Affairs Outsourcing Market for GAP-Analysis, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.65. Medical Device Regulatory Affairs Outsourcing Market for Legal Representation, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.66. Medical Device Regulatory Affairs Outsourcing Market for Notified Body Selection, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.67. Medical Device Regulatory Affairs Outsourcing Market for Product Labelling-Related Services, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.68. Medical Device Regulatory Affairs Outsourcing Market for Product Registration and Clinical Trial Applications, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.69. Medical Device Regulatory Affairs Outsourcing Market for Regulatory Writing and Publishing, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.70. Medical Device Regulatory Affairs Outsourcing Market for Regulatory Document Submissions, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.71. Medical Device Regulatory Affairs Outsourcing Market for Technical Dossier Set-Up, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.72. Medical Device Regulatory Affairs Outsourcing Market for Vigilance & Medical Device Report, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.73. Medical Device Regulatory Affairs Outsourcing Market: Distribution by Device Class, 2019 and 2030 (USD Million)
Table 15.74. Medical Device Regulatory Affairs Outsourcing Market for Class I Devices, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.75. Medical Device Regulatory Affairs Outsourcing Market for Class II Devices, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.76. Medical Device Regulatory Affairs Outsourcing Market for Class III Devices, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.77. Medical Device Regulatory Affairs Outsourcing Market: Distribution by Therapeutic Area, 2019 and 2030 (USD Million)
Table 15.78. Medical Device Regulatory Affairs Outsourcing Market for Cardiovascular Disorders, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.79. Medical Device Regulatory Affairs Outsourcing Market for Central Nervous System Disorders, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.80. Medical Device Regulatory Affairs Outsourcing Market for Metabolic Disorders, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.81. Medical Device Regulatory Affairs Outsourcing Market for Oncological Disorders, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.82. Medical Device Regulatory Affairs Outsourcing Market for Orthopedic Disorders, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.83. Medical Device Regulatory Affairs Outsourcing Market for Ophthalmic Disorders, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.84. Medical Device Regulatory Affairs Outsourcing Market for Pain Disorders, 2019-2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.85. Medical Device Regulatory Affairs Outsourcing Market for Respiratory Disorders, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.86. Medical Device Regulatory Affairs Outsourcing Market for Other Therapeutic Areas, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.87. Medical Device Regulatory Affairs Outsourcing Market for GAP-Analysis in North America, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.88. Medical Device Regulatory Affairs Outsourcing Market for GAP-Analysis in Europe, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.89. Medical Device Regulatory Affairs Outsourcing Market for GAP-Analysis in Asia-Pacific, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.90. Medical Device Regulatory Affairs Outsourcing Market for GAP-Analysis in Rest of the World, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.91. Medical Device Regulatory Affairs Outsourcing Market for Legal Representation in North America, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.92. Medical Device Regulatory Affairs Outsourcing Market for Legal Representation in Europe, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.93. Medical Device Regulatory Affairs Outsourcing Market for Legal Representation in Asia-Pacific, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.94. Medical Device Regulatory Affairs Outsourcing Market for Legal Representation in Rest of the World, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.95. Medical Device Regulatory Affairs Outsourcing Market for Notified Body Selection in North America, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.96. Medical Device Regulatory Affairs Outsourcing Market for Notified Body Selection in Europe, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.97. Medical Device Regulatory Affairs Outsourcing Market for Notified Body Selection in Asia-Pacific, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.98. 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 15.99. Medical Device Regulatory Affairs Outsourcing Market for Product Labelling-Related Services in North America, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.100. Medical Device Regulatory Affairs Outsourcing Market for Product Labelling-Related Services in Europe, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.101. Medical Device Regulatory Affairs Outsourcing Market for Product Labelling-Related Services in Asia-Pacific, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.102. Medical Device Regulatory Affairs Outsourcing Market for Product Labelling-Related Services 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 Registration and Clinical Trial Applications in North America, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.104. 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 15.105. 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 15.106. 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 15.107. Medical Device Regulatory Affairs Outsourcing Market for Regulatory Writing and Publishing in North America, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.108. Medical Device Regulatory Affairs Outsourcing Market for Regulatory Writing and Publishing in Europe, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.109. Medical Device Regulatory Affairs Outsourcing Market for Regulatory Writing and Publishing in Asia-Pacific, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.110. 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 15.111. Medical Device Regulatory Affairs Outsourcing Market for Regulatory Document Submissions in North America, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.112. Medical Device Regulatory Affairs Outsourcing Market for Regulatory Document Submissions in Europe, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.113. Medical Device Regulatory Affairs Outsourcing Market for Regulatory Document Submissions in Asia-Pacific, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.114. 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 15.115. Medical Device Regulatory Affairs Outsourcing Market for Technical Dossier Set-Up in North America, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.116. Medical Device Regulatory Affairs Outsourcing Market for Technical Dossier Set-Up in Europe, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.117. Medical Device Regulatory Affairs Outsourcing Market for Technical Dossier Set-Up in Asia-Pacific, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.118. 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 15.119. Medical Device Regulatory Affairs Outsourcing Market for Vigilance & Medical Device Report in North America, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.120. Medical Device Regulatory Affairs Outsourcing Market for Vigilance & Medical Device Report in Europe, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.121. Medical Device Regulatory Affairs Outsourcing Market for Vigilance & Medical Device Report in Asia-Pacific, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.122. 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 15.123. Medical Device Regulatory Affairs Outsourcing Market for Class I Devices in North America, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.124. Medical Device Regulatory Affairs Outsourcing Market for Class I Devices in Europe, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.125. Medical Device Regulatory Affairs Outsourcing Market for Class I Devices in Asia-Pacific, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.126. 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 15.127. Medical Device Regulatory Affairs Outsourcing Market for Class II Devices in North America, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.128. Medical Device Regulatory Affairs Outsourcing Market for Class II Devices in Europe, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.129. Medical Device Regulatory Affairs Outsourcing Market for Class II Devices in Asia-Pacific, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.130. 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 15.131. Medical Device Regulatory Affairs Outsourcing Market for Class III Devices in North America, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.132. Medical Device Regulatory Affairs Outsourcing Market for Class III Devices in Europe, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.133. Medical Device Regulatory Affairs Outsourcing Market for Class III Devices in Asia-Pacific, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.134. 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 15.135. Medical Device Regulatory Affairs Outsourcing Market for Cardiovascular Disorders in North America, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.136. Medical Device Regulatory Affairs Outsourcing Market for Cardiovascular Disorders in Europe, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.137. Medical Device Regulatory Affairs Outsourcing Market for Cardiovascular Disorders in Asia-Pacific, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.138. Medical Device Regulatory Affairs Outsourcing Market for Cardiovascular Disorders in Rest of the World, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.139. Medical Device Regulatory Affairs Outsourcing Market for Central Nervous System Disorders in North America, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.140. Medical Device Regulatory Affairs Outsourcing Market for Central Nervous System Disorders in Europe, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.141. Medical Device Regulatory Affairs Outsourcing Market for Central Nervous System Disorders in Asia-Pacific, 2019-2030 (USD Million)
Table 15.142. 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 15.143. Medical Device Regulatory Affairs Outsourcing Market for Metabolic Disorders in North America, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.144. Medical Device Regulatory Affairs Outsourcing Market for Metabolic Disorders in Europe, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.145. Medical Device Regulatory Affairs Outsourcing Market for Metabolic Disorders in Asia-Pacific, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.146. Medical Device Regulatory Affairs Outsourcing Market for Metabolic Disorders in Rest of the World, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.147. Medical Device Regulatory Affairs Outsourcing Market for Oncological Disorders in North America, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.148. Medical Device Regulatory Affairs Outsourcing Market for Oncological Disorders in Europe, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.149. Medical Device Regulatory Affairs Outsourcing Market for Oncological Disorders in Asia-Pacific, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.150. Medical Device Regulatory Affairs Outsourcing Market for Oncological Disorders in Rest of the World, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.151. Medical Device Regulatory Affairs Outsourcing Market for Ophthalmological Disorders in North America, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.152. Medical Device Regulatory Affairs Outsourcing Market for Ophthalmological Disorders in Europe, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.153. Medical Device Regulatory Affairs Outsourcing Market for Ophthalmological Disorders in Asia-Pacific, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.154. Medical Device Regulatory Affairs Outsourcing Market for Ophthalmological Disorders in Rest of the World, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.155. Medical Device Regulatory Affairs Outsourcing Market for Orthopedic Disorders in North America, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.156. Medical Device Regulatory Affairs Outsourcing Market for Orthopedic Disorders in Europe, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.157. Medical Device Regulatory Affairs Outsourcing Market for Orthopedic Disorders in Asia-Pacific, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.158. Medical Device Regulatory Affairs Outsourcing Market for Orthopedic Disorders in Rest of the World, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.159. Medical Device Regulatory Affairs Outsourcing Market for Pain Disorders in North America, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.160. Medical Device Regulatory Affairs Outsourcing Market for Pain Disorders in Europe, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.161. Medical Device Regulatory Affairs Outsourcing Market for Pain Disorders in Asia-Pacific, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.162. Medical Device Regulatory Affairs Outsourcing Market for Pain Disorders in Rest of the World, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.163. Medical Device Regulatory Affairs Outsourcing Market for Respiratory Disorders in North America, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.164. Medical Device Regulatory Affairs Outsourcing Market for Respiratory Disorders in Europe, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.165. Medical Device Regulatory Affairs Outsourcing Market for Respiratory Disorders in Asia-Pacific, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.166. Medical Device Regulatory Affairs Outsourcing Market for Respiratory Disorders in Rest of the World, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.167. Medical Device Regulatory Affairs Outsourcing Market for Other Disorders in North America, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.168. Medical Device Regulatory Affairs Outsourcing Market for Other Disorders in Europe, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.169. Medical Device Regulatory Affairs Outsourcing Market for Other Disorders in Asia-Pacific, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.170. Medical Device Regulatory Affairs Outsourcing Market for Other Disorders in Rest of the World, 2019-2030: Conservative, Base and Optimistic Scenarios (USD Million)
Table 15.171. Survey Insights: Distribution of Respondents by Year of Establishment of Company
Table 15.172. Survey Insights: Distribution of Respondents by Employee Size
Table 15.173. Survey Insights: Distribution of Respondents by Location of Company Headquarters (Continent-Wise)
Table 15.174. Survey Insights: Distribution of Respondents by Location of Company Headquarters (Country-Wise)
Table 15.175. Survey Insights: Distribution by Designation and Seniority Level
Table 15.176. Survey Insights: Distribution by Types of Services
Table 15.177. Survey Insights: Distribution by Market Access
Table 15.178. Survey Insights: Distribution by Type and Size of Clientele
Table 15.179. Survey Insights: Distribution by Number of Projects
Table 15.180. Survey Insights: Distribution by Proportion of Clients Outsourcing Regulatory Affairs-Related Services
Table 15.181. Survey Insights: Distribution by Current and Future Market Opportunity

Companies Mentioned

1MED SA
4Clinics
A+ Science
Abbott
ABIOGENESIS CLINPHARM
ABX-CRO
Accell Clinical Research
Accredited Consultants
Accutest Global
Acorn Regulatory Consultancy Services
Acrapack
acromion
aCROss Medical
Activa Cro
Actolis
ADAX International
Advanced Medical Research (AMR)
Advena
AE Performance Testing Lab
Affinity Bio Partners
Afra Pharma Consultant
AG Mednet
Aginko Research
AICROS
Al Tamimi
Allied Clinical Management
Allscripts Healthcare Solutions
Alquest
ALTIORA
Amarex
American Preclinical Services
AmeRuss
Amritt
analyze & realize
Andaman Medical
Anteris Medical
ANTRIX
A-pharmaconsult
apices
APO Plus Station
Appletree CI Group
Arazy Group Consultants
ARC Pharma
Archemin
Arlenda
ARQon
Asia Actual
ATLANSTAT
AtoZ-CRO
Australian Healthcare Solutions
Auxilife Scientific Services
AVANTI
AVIAD Life Sciences
Axonal-Biostatem
Azelix
Barons Medical Consulting
Beaufort
Becton Dickinson
Beijing JRJ Science and technology
BIC Group
BioAgile Therapeutics
BIOCODEX Nordics
BioFortis
Biomapas
Biomedical Regulatory Consulting
Biomedical Strategy
BioMotiv
BioPlan
Biorasi
Bioreg Services
Bioscience
Biotech Regulatory Solutions
BioTeknica
BiTrial Clinical Research
BLAU Pharmaceutical Service
Boston Biomedical Associates (BBA)
Boston MedTech Advisors
Boston Scientific
Brandwood CKC
Bridge Pharm
BSI
Cactus Global
Cardinal Health
CardioMed Device Consultants
Cardiovascular European Research Center (CERC)
CARSL Consulting
Catawba Research
Cato Research (CATO)
CC Clinical research Consultants
Ceetox
C'en Al Research
CERES
CHA Medical Group
Charles River Laboratories
ChemADVISOR
Chemical Inspection and Regulation Service (CIRS)
China Med Device
Chris Freer Associates
Clarivate Analytics
ClinAudits
ClinDatrix
Clinical Device Group
Clinical Research & Compliance Consulting
Clinical Trial Data Services
CliniExperts
Clinilabs
Clinipace
Clinlogix
Clinmark
ClinMed Pharma
ClinSync
Clintec
CMIC Group
CMX Research
Cobridge
Commercial Eyes
ComplianceAcuity
Complya Consulting
CONET
Consultys Switzerland
Convex
Costello Medical
Courante Oncology
CPS Cortex
Creganna Medical
Criterium
Cromos Pharma
CROMSOURCE
CROs NT
Crown CRO
CSSi LifeSciences
CTI
CTNT
CurAccel
CW Research & Management
CYA Medical Device Consulting
Dalia Givony, Regulatory & Clinical Consulting
Databean
Datapharm Australia
Datavant
Datavant
De Groot Technical Services
DEKRA
devicia
DH RegSys
dicentra
DiscGenics
DKSH Marketing Services Spain
dMed
Donawa Lifescience Consulting
Dor Pharmaceutical Services
DP Clinical
DSA Consultants
DuPage Medical Group
EAS Consulting Group
EG Mont Brazil
Eli Lily
Emergo
Engel, Hellyer & Partners
EPIC Research
Essilor
ESTERN Medical
Ethicare
EuDRAcon
Eurofins Scientific
Eurotrials
Evidilya
Exalon
ExecuPharm
Factory CRO
FDAInsight
Fermish Clinical Technologies
FGK Clinical Research
FMD K&L
Focal Point Research
Fountain Medical Development (FMD)
Fresenius Medical Care
Freyr
GCP-Service International
GE Healthcare
genae
Genco Medical
Genelife Clinical Research
Genpact
George Clinical
Getz Healthcare
GKM
Global Pharma Tek
Global Regulatory Affairs (GRA)
Global Regulatory Partners
Global Regulatory Services
Green Building Japan (GBJ)
Grove Group
Gsap
Gulf Medical Devices Consultancy
Health Advances
Health Sciences
Healthcare International Partners
HealthLink
HingeClinica
HungaroTrial
I 3 CONSULTING
ICBio
ICON
ICRC-Weyer
ICTA
idcOnic
Illingworth Research Group
INE G-MED (through G-MED North America)
Innomar Strategies (a part of AmerisourceBergen)
Inrextest
Integrated Resources CRO Division
Intel
International HealthCare (IHC)
Intertek Group
Ipsum
IQVIA
Iris Pharma
Ironstone Product Development
IRW
ISA HEALTH
ITEC Services
IVDeology
IZiel Healthcare
J Knipper
Japan MDC (JMDC)
Johnson & Johnson
JSS Medical Research
KCR
KCRI
KD&A
Ken Block Consulting
Kensington Swan
Keystone Regulatory Services
Kiana Systems
Kinapse
KLIFO
Knoell
Kobridge Consulting
KPS Clinical Services
L.S Marketing & Registration
LabCorp
Lambda Therapeutic Research
Larix
Lean RAQA
Leon Research
Li-Med RA & QA Experts
Linical
LINK Medical
LIONBRIDGE
LNAge
MakroCare
Malca Chen-Zion Group
MANDALA International
Mapi Group
MasterControl
MAXIS
McCarthy Consultant Services
McGee Pharma International (MPI)
McMillan Research
MD101 Consulting
MD-Clinicals
mdi Consultants
mdi Europa
MDP Solutions
MED Institute
Medelis
Medfiles Group
Medical Equipment Compliance Association
Medidee
MeDiNova Research
MediqTrans
Meditrial
MEDITRIAL
Meditrial Europe
MedNet
Medpace
MedPass International
MedQ Consultants
Medtronic
Medvance
Meiji Pharmaceutical University (MPU)
Mene Research
Mericon
Meshayu Consultants
MethodSense
Metrics Research
MIC Medical
Micren Healthcare
Microsoft
Mid-Link Consulting
Mn Solutions
Mobius Medical
MolecularMD
Morley Research Consortium
Morula HealthTech
Musculoskeletal Clinical Regulatory Advisers (MCRA)
NAGLREITER
NAMSA
Navitas Life Sciences
NCGS
NEOMED Services
Neopharm
Neox Clinical Research
Neozene
Nerac
New England Research Institutes (NERI)
NHP Consulting
Nordic Health Economics AB (NHE)
Northlane Capital Partners
Northside consulting
Novartis
NovaTrials
Novem Healthcare
Novotek
Novum
NSF International
Nyprax Pharma
O4 Research
Obelis Group
OmniComm Systems
Onorach
Operon Strategist
OPIS
Ora
Osmunda
Pace Analytical
Pacific Bridge Medical
Pacific Clinical Research Group (PCRG)
Parexel
PAREXEL Biotech
Paxmed Interational
Pearl Pathways
Pepgra
Perfect Pharmaceuticals Consultants
Perfection-CRO
Pharma to Market
Pharmaceutical Regulatory Services
Pharmaceutical Solutions
Pharmaco-Kinesis
Pharmahungary Group
PharmaLex
PharmaMed Global (through AJW Technology Consultants)
PharmaMed Research
PharmDedict
PharmEng Regulatory Affairs
PharmOut
Phidea Group
Pivotal
PPD
PQE Group
PRA International
Practice Fusion
PRC Clinical
Precision Medicine Group
Premier Research
Professional Regulatory Affairs
Profil
Promedica International
ProMedoss
ProPharma Group
Prosoft Clinical
ProTrials
Proxima Clinical Research
Pharmaceutical and Regulatory Services (PRSG)
Q&R Canada
QA Consulting
QAdvis
Qmed Consulting
Qserve Group
QST Consultations
Q-Trials
Qualitiso
Qualtech Consulting
Quanticate
Quantum Solutions India
Quantum Solutions India (QSI)
QUNIQUE
R & C Consulting Group
R&G PharmaStudies
R&Q
RAMED
RCQ Solutions
RCRI
ReadyClinical
Reg-Affairs & QualiPractixis
RegDesk
Registrar Corp
Regulatory Compliance Associates
Regulatory Insight
Regulatory Professionals
Reimbursement Strategies
Research Professionals
RGL Research
Rho
Rook Quality Systems
RQMIS
RQSolutions
RTI Health Solutions
Safis Solutions
Samsung Medical Center
Saudi Telecom Company (STC)
Scandinavian CRO
Scandinavian Regulatory Services (SRS)
Scope International
SeerPharma
Sentez CRO
Seoul CRO
SEQ
SGS
Shanghai QiSheng Business Consulting
SHYFT Analytics
Sidley Austin
Siemens
Simmons & Simmons
Sipra Labs
Sixmurs Group
Society for Clinical Research Sites
Southern Star Research
SPARTA
SPharm
StarFish Medical
STATKING Clinical Services
SteriPack Group
SterlingBio
Strategic Compliance International
StrugoPharm
Stryker
Sumika Chemical Analysis Service (SCAS)
SunFlare
Symbioteq
Syneos Health
Syntax
Synteract
TAB Clinical
TCA Clinical Research
TechnoSTAT
Telecommunications Industry Association (TIA)
The CLINICAL TRIAL Company Group
The CRO Group
The Integra Group
The Society for Clinical Research Sites (SCRS)
The Weinberg Group
Thema Med
Theo Manufacturing
TheraGenesis
TPIreg
TRAC
TransPerfect Life Sciences
Trial Form Support International (TFS) (Acquired by Ratos)
Turacoz Healthcare Solutions
TÜV SÜD-Healthcare & Medical Devices
UBC
Ulmer Ventures
Underwriters Laboratory (UL)
Unikal Consultants
Vantage BioTrials
Vantage Consulting International
Venn Life Sciences
Veristat
VOLER Biotech Consulting
Volv
Vyomus Consulting
WCCT Global
Wipro
Wonderville
WOODLEY BIOREG
Wuxi AppTec
Zeincro
Zi-Medical
Zimmer Biomet
Zwiers Regulatory Consulting

Methodology

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Table of Contents

Companies Mentioned

Methodology

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