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Medical Device Regulation

- FDA-CDRH Manufacturing, Policies and Regulation Handbook

  • Format
  • E-bog, ePub
  • Engelsk
  • 678 sider
E-bogen er DRM-beskyttet og kræver et særligt læseprogram

Beskrivelse

Medical Device Regulation provides the current FDA-CDRH thinking on the regulation of medical devices. This book offers information on how devices meet criteria for being a medical device, which agencies regulate medical devices, how policies regarding regulation affect the market, rules regarding marketing, and laws and standards that govern testing. This practical, well-structured reference tool helps medical device manufacturers both in and out of the United States with premarket application and meeting complex FDA regulatory requirements. The book delivers a comprehensive overview of the field from an author with expertise in regulatory affairs and commercialization of medical devices. - Offers a unique focus on the regulatory affairs industry, specifically targeted at regulatory affairs professionals and those seeking certification- Puts regulations in the context of contemporary design- Includes case studies and applications of regulations

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Detaljer
  • SprogEngelsk
  • Sidetal678
  • Udgivelsesdato24-02-2023
  • ISBN139780323953535
  • Forlag Elsevier Science
  • FormatePub

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