Medical Device Regulation: FDA-CDRH Manufacturing, Policies and Regulation Handbook -Original PDF
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Amazon Price $267.68 | By Wreh | Size : 6.75 MB
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.
Product Details
- Publisher : Academic Press (Feb. 24 2023)
- Language : English
- Paperback : 678 pages
- ISBN-10 : 0323953549
- ISBN-13 : 978-0323953542
- Item weight : 1.4 kg
- Dimensions : 19.1 x 3.89 x 23.5 cm