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Medical Device Regulation: Fda-Cdrh Manufacturing, Policies and Regulation Handbook (in English)
Elijah Wreh (Author)
·
Academic Press
· Paperback
Medical Device Regulation: Fda-Cdrh Manufacturing, Policies and Regulation Handbook (in English) - Elijah Wreh
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Synopsis "Medical Device Regulation: Fda-Cdrh Manufacturing, Policies and Regulation Handbook (in English)"
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.
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All books in our catalog are Original.
The book is written in English.
The binding of this edition is Paperback.
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