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The contract regulatory affairs-management services market for medical devices is estimated to be worth USD 820 million by 2030, growing at a CAGR of 6.9%, claims Roots Analysis
Over the years, outsourcing has become a popular trend withthe medical device industry, allowing innovators to leverage the technical andregulatory expertise of contract service providers in order to expedite time tomarket

Over the years, outsourcing has become a popular trend withthe medical device industry, allowing innovators to leverage the technical andregulatory expertise of contract service providers in order to expedite time tomarket

 

Roots Analysis is pleased to announce the publication of its recentstudy, titled, “MedicalDevice CROs for Regulatory Affairs Management Market, 2019-2030.”

 

The report features a detailed study on the currentlandscape of contract service providers focused on regulatory affairsmanagement 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 reportincludes:

§  Adetailed review of the current market landscape of the medical devicesregulatory affairs outsourcing market, featuring a list of over 400 CROsengaged in this domain.

§  Adetailed discussion on the need for regulatory review / oversight acrossdifferent stages of the medical devices supply chain, with emphasis on theoptimization of the supply chain using upcoming tools / technologies.

§  Anelaborate discussion on the various guidelines established by major regulatorybodies for medical device approval across North America, Europe, Asia-Pacificand rest of the world.

§  Elaborateprofiles of popular players that specialize in offering end-to-end regulatoryservices for medical devices across key geographies.

§  Abenchmark analysis, highlighting the key focus areas of very small-sized,small-sized, mid-sized and large companies, comparing their existingcapabilities within and beyond their respective peer groups.

§  Anelaborate discussion on the various outsourcing business models adopted forregulatory affairs management, along with an insightful Harvey ball analysis ofkey considerations that need to be assessed by industry stakeholders whileselecting a CRO partner.

§  Ananalysis highlighting the key performance indicators used by sponsor companiesto evaluate service providers that are active in the domain, based oninformation gathered via secondary research (for top-ten medical deviceplayers) and primary research.

§  Asurvey analysis featuring inputs solicited from various experts who aredirectly / indirectly involved in providing regulatory affairs managementservices to medical device developers.

§ A detailed market forecast, featuring analysis of thecurrent and projected future opportunity across key market segments (listedbelow)

 

§  MedicalDevice Class

§  ClassI

§  ClassII

§  ClassIII

 

§  TherapeuticArea

§  CardiovascularDisorders

§  CNSDisorders

§  MetabolicDisorders

§  OncologicalDisorders

§  OphthalmologicalDisease

§  OrthopedicDisorders

§  PainDisorders

§  RespiratoryDisorders

§  Others

 

§  Typeof Regulatory Affairs Service

§  PharmaciesGAP-Analysis

§  PharmaciesLegal Representation

§  PharmaciesNotified Body Selection

§  ProductLabelling-related Services

§  ProductRegistration and Clinical Trial Applications

§  RegulatoryDocument Submissions

§  RegulatoryWriting and Publishing

§  RiskManagement-related Services

§  TechnicalDossier Set-up

§  Vigilance& Medical Device Report

 

§  KeyGeographical Regions

§  NorthAmerica

§  Europe

§  Asia-Pacificand Rest of the World

 

Keycompanies covered in the report

§ 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)

 

Formore information please click on the following link

https://www.rootsanalysis.com/reports/view_document/med-dev-regulatory/282.html  

 

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About Roots Analysis

Roots Analysis is one of the fastest growing marketresearch companies, sharing fresh and independent perspectives in thebio-pharmaceutical industry. The in-depth research, analysis and insights aredriven by an experienced leadership team which has gained many years ofsignificant experience in this sector. If you’d like help with your growingbusiness needs, get in touch at info@rootsanalysis.com

 

Contact Information

Roots Analysis Private Limited

Gaurav Chaudhary

+1 (415) 800 3415

gaurav.chaudhary@rootsanalysis.com