Over 400 companies claim to possess the required expertise to offer regulatory affairs management-re

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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• A detailed review of the current market landscape of the medical devices regulatory affairs outsourcing market, featuring a list of over 400 CROs engaged in this domain, and detailed analysis based on a number of relevant parameters, such as year of establishment, size of employee base, geographical location, device class (class I, class II, and class III), type and size of clientele (medical device developers, medical device manufacturers, medical device research organizations, and others), types of services offered, ([A] regulatory management services (such as legal representation, notified body selection, project registration and clinical trial application, regulatory writing and publishing, regulatory document submission, product labelling related service, gap-analysis, technical dossier set-up, vigilance & medical device report, risk management-related services), [B] additional services (such as biostatistics, consulting, clinical operations, post-marketing activities, quality assurance, reimbursement, training)), region(s) of operation wherein the company is offering regulatory management services.
• A detailed discussion on the need for regulatory review / oversight across different stages of the medical devices supply chain, with emphasis on the optimization of the supply chain using upcoming tools / technologies (such as artificial intelligence, big data analytical, blockchain, internet of things and others).

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

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Contact Details

Gaurav Chaudhary

+1 (415) 800 3415

gaurav.chaudhary@rootsanalysis.com

Roots Analysis is one of the fastest growing market research companies, sharing fresh and independent perspectives in the bio-pharmaceutical industry. www.RootsAnalysis.com