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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 with
the medical device industry, allowing innovators to leverage the technical and
regulatory expertise of contract service providers in order to expedite time to

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

The 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

§ 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.

§ 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.

§ An
elaborate discussion on the various guidelines established by major regulatory
bodies for medical device approval across North America, Europe, Asia-Pacific
and rest of the world.

§ Elaborate
profiles of popular players that specialize in offering end-to-end regulatory
services for medical devices across key geographies.

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

§ 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.

A detailed market forecast, featuring analysis of the
current and projected future opportunity across key market segments (listed

§ Medical
Device Class

§ Class

§ Class

§ Class

§ Therapeutic

§ Cardiovascular


§ Metabolic

§ Oncological

§ Ophthalmological

§ Orthopedic

§ Pain

§ Respiratory

§ Others

§ Type
of Regulatory Affairs Service

§ Pharmacies

§ 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

§ Europe

§ Asia-Pacific
and Rest of the World

companies covered in the report

CTI Clinical Trial and Consulting Services





MIC Medical

North American Science Associates (NAMSA)



Premier Research

Société Générale de Surveillance (SGS)

Underwriters Laboratory (UL)

more information please click on the following link


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About Roots Analysis

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

Contact Information

Roots Analysis Private Limited

Gaurav Chaudhary

+1 (415) 800 3415