Medical Device Regulation: Fda-Cdrh Manufacturing, Policies and Regulation Handbook

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.

Author: Elijah Wreh
Publisher: Academic Press
Published: 02/24/2023
Pages: 678
Binding Type: Paperback
Weight: 2.53lbs
Size: 9.25h x 7.50w x 1.36d
ISBN13: 9780323953542
ISBN10: 0323953549
BISAC Categories:
- Technology & Engineering | Engineering (General)

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