Medical Device Regulation: FDA-CDRH Manu, 9780323953542

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Medical Device Regulation: FDA-CDRH Manufacturing, Policies and Regulation Handbook

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ISBN 9780323953542
Author: Wreh, Elijah (Adjunct Professor, Case Western Rese
Publ Date: 2023-02-01
Edition: 1
Binding: Paperback / softback

$404.35
Sale: $363.92
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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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Medical Device Regulation: FDA-CDRH Manufacturing, Policies and Regulation Handbook

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Medical Device Regulation: FDA-CDRH Manufacturing, Policies and Regulation Handbook

$404.35 Sale: $363.92Save: 10% off + GST

$404.35
Sale: $363.92
Save: 10% off + GST