Medical Device Regulation : FDA-CDRH Manufacturing, Policies and Regulation Handbook
by
Elijah Wreh
Book Details
Format
Paperback / Softback
ISBN-10
0323953549
ISBN-13
9780323953542
Publisher
Elsevier Science & Technology
Imprint
Academic Press Inc
Country of Manufacture
NL
Country of Publication
GB
Publication Date
Feb 24th, 2023
Print length
678 Pages
Weight
1,338 grams
Dimensions
19.00 x 23.50 x 3.80 cms
Product Classification:
Regulation of medicines & medical devices
Ksh 27,900.00
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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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