More than 130 medical devices were approved by the FDA since January 2018, while several are currently being evaluated across more than 9,500 (active) clinical trials, worldwide. Even though technical innovation has enabled the development of a variety of versatile medical devices, product approval, given stringent regulatory standards, is still a concern.

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The USD 820 million (by 2030) financial opportunity within the contract regulatory affairs-management services market for medical devices has been analyzed across the following segments:
 Medical Device Class
 Class I
 Class II
 Class III

 Therapeutic Area
 Cardiovascular Disorders
 CNS Disorders
 Metabolic Disorders
 Oncological Disorders
 Ophthalmological Disease
 Orthopedic Disorders
 Pain Disorders
 Respiratory Disorders
 Others

 Type of Regulatory Affairs Service
 Pharmacies GAP-Analysis
 Pharmacies Legal Representation
 Pharmacies Notified Body Selection
 Product Labelling-related Services
 Product Registration and Clinical Trial Applications
 Regulatory Document Submissions
 Regulatory Writing and Publishing
 Risk Management-related Services
 Technical Dossier Set-up
 Vigilance & Medical Device Report

 Key Geographical Regions
 North America
 Europe
 Asia-Pacific and Rest of the World

The Contract Regulatory Affairs-Management Market for Medical Devices, 2019-2030 report features the following companies, which we identified to be key players in this domain:
 CTI Clinical Trial and Consulting Services
 CROMSOURCE
 ICON
 Intertek
 Medpace
 MIC Medical
 North American Science Associates (NAMSA)
 Parexel
 PharmaLex
 Premier Research
 Société Générale de Surveillance (SGS)
 Underwriters Laboratory (UL)

Table of Contents

1. Preface

2. Executive Summary

3. Introduction

4. Role of Regulatory Affairs in Medical Device Supply Chain

5. Regulatory and Reimbursement Landscape for Medical Devices

6. Competitive Landscape

7. Company Profiles

8. Competitive Benchmarking

9. Guide to Regulatory Outsourcing Models

10. Medical Device Regulatory Affairs: Key Performance Indicators

11. Market Forecast

12. Conclusion

13. Survey Insights

14. Executive Insights

15. Appendix 1: Tabulated Data

16. Appendix 2: List of Companies and Organizations

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Contact Details
Gaurav Chaudhary
+1 (415) 800 3415
[email protected]