RootsAnalysis

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Contract Regulatory Affairs Management Market for
Medical Devices, 2019-2030

• Roots Analysis

https//www.rootsanalysis.com/reports/view_documen
t/med-dev-regulatory/282.html https//www.rootsana
lysis.com/
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Overview

• According to the World Bank, more than 50,000
  different types of medical devices are currently
  being used on a daily basis in healthcare
  facilities across the globe. In 2018, the global
  medical devices market was estimated to have
  reached a net worth of approximately USD 450
  billion. It is also worth noting that, since
  January 2018, the USFDA approved over 130 medical
  devices. However, a relatively large proportion
  of developers lack the resources and technical
  expertise required to handle regulatory filings
  and effectively manage the processes associated
  with procuring marketing authorizations from
  regional regulators. Moreover, keeping up with
  evolving regulatory guidelines, rising costs of
  legal advice and increasing effort required for
  preparing of technical documentation, is
  difficult for companies with limited finances. In
  addition, establishing reimbursement strategies
  for medium to high-risk devices is also a
  complicated process and innovator companies
  usually do not have the expertise to deal with
  payers and insurance providers. According to a
  recent report, 68 of medical device companies
  reports prepared and submitted by in-house
  players are either rejected or were reported to
  have multiple major gaps in their clinical
  evaluation report (CER) and supporting evidences
  by the notified bodies. In fact. in a survey
  published in the 2016 edition of Global Medical
  Device Supply Chain, regulatory requirements were
  highlighted among the primary areas of concern
  within the medical device value chain.
  Furthermore, the implementation of highly
  stringent regulatory guidelines, specifically for
  devices posing medium to high risk to consumers,
  render them subject to rigorous quality
  assessments.

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Scope of the Report

• The Contract Regulatory Affairs Management
  Market for Medical Devices, 2019-2030 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
  includes
• 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, and popular therapeutic area(s).

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• 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).
• An elaborate discussion on the various guidelines
  established by major regulatory bodies for
  medical device approval across North America (the
  US, Canada and Mexico), Europe (France, Germany,
  Italy, Spain, the UK and rest of Europe),
  Asia-Pacific and rest of the world (Australia,
  Brazil, China, India, Israel, Japan, New Zealand,
  Singapore, South Africa, South Korea, Taiwan, and
  Thailand). The report also features an insightful
  multi-dimensional, heat map analysis, featuring a
  comparison of the contemporary regulatory and
  reimbursement scenarios in key geographies across
  the globe.
• Elaborate profiles of popular players that
  specialize in offering end-to-end regulatory
  services for medical devices across key
  geographies (North America, Europe and
  Asia-Pacific). Each profile features a brief
  overview of the company, including information on
  company headquarters, year of establishment,
  number of employees, and therapeutic area
  expertise, financial information (if available),
  detailed description of service portfolio, and an
  informed future outlook.
• A benchmark analysis, highlighting the key focus
  areas of small-sized, mid-sized and large
  companies, comparing their existing capabilities
  within and beyond their respective peer groups,
  providing a means for stakeholders to identify
  ways to gain a competitive edge in the industry.
• 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.

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Contents

• Chapter Outlines
• Chapter 2 provides an executive summary of the
  insights captured in our research. It offers a
  high-level view on the current state of the
  medical device regulatory affairs management CROs
  market and its likely evolution in the
  short-midterm and long term.
• Chapter 3 is a general overview of the various
  types of CROs that offer services to the medical
  devices industry. It provides a brief
  introduction to the concept of CROs, featuring a
  discussion on the historical evolution of
  contract research services market in this domain.
  Further, it elaborates on the need for
  outsourcing in this domain, along with the
  various partnership models that have been adopted
  by CROs and medical device developers. In
  addition, the chapter highlights key points that
  developer companies need to consider for
  selecting a suitable contract research services
  provider for regulatory management services. It
  also features a detailed list of regulatory
  management services offered by contemporary CROs,
  along with a discussion on the various challenges
  within the market.
• Chapter 4 includes a detailed discussion on the
  need of regulatory review / oversight across
  different stages of the medical device supply
  chain. It also emphasizes on the various factors
  that are likely to impact the performance of the
  medical device supply chain, along with
  strategies that are likely to assist in improving
  visibility in the supply chain. Subsequently, the
  chapter provides information on optimization of
  the supply chain using upcoming tools /
  technologies (such as artificial intelligence,
  big data analytical, blockchain, internet of
  things and others).
• Chapter 5 features a discussion on the various
  guidelines established by major regulatory bodies
  for medical device approvals

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• For additional details, please visit
• https//www.rootsanalysis.com/reports/view_documen
  t/cell-therapies-supply-chain/260.html
• or email sales_at_rootsanalysis.com
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• Contact
• Gaurav Chaudhary
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• 44 [phone]
• Gaurav.Chaudhary_at_rootsanalysis.com