Medical Device Regulation
ISBN: 9780323953542
Author : Elijah Wreh
Published: 2023
Publisher: Academic Press
Language: English
Format: Paperback / softback
Format: 9.25×7.5
Author : Elijah Wreh
Published: 2023
Publisher: Academic Press
Language: English
Format: Paperback / softback
Format: 9.25×7.5
Description
<i>Medical Device Regulation</i> 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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