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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Key Market Insights
§ Over 400 companies claim to possess the required expertise to offer regulatory affairs management-related services to medical device-focused business entities
§ A detailed review of the current Medical Device CRO market landscape of the medical devices regulatory affairs outsourcing market, featuring a list of over 400 CROs engaged in this domain.
§ The market landscape is highly fragmented, featuring the presence of both established players and new entrants; majority of such firms are located in the developed geographies
§ Service providers are catering to a diverse clientele, enabling sponsors to compliance to the standards of both regional and international regulators
§ Owing to the high competition, companies involved in this domain are steadily expanding their capabilities in order to augment their respective service portfolios and comply to evolving industry benchmarks
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 Medical Device CROs Market, 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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