Elijah Wreh

Medical Device Regulation (eBook, ePUB)

FDA-CDRH Manufacturing, Policies and Regulation Handbook

• Format: ePub

Produktbeschreibung

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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Produktdetails

• Verlag: Elsevier Science & Techn.
• Seitenzahl: 678
• Erscheinungstermin: 22. Februar 2023
• Englisch
• ISBN-13: 9780323953535
• Artikelnr.: 67500938