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Medical Device Regulation - FDA-CDRH Manufacturing, Policies and Regulation Handbook (Paperback)
Loot Price: R3,965
Discovery Miles 39 650
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Medical Device Regulation - FDA-CDRH Manufacturing, Policies and Regulation Handbook (Paperback)
Expected to ship within 10 - 15 working days
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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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