Open Daily: 10am - 10pm | Alley door pickup 10am - 7pm 3038 Hennepin Ave Minneapolis, MN
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  • Open Daily: 10am - 10pm
    Alley-side Pickup: 10am - 7pm

    3038 Hennepin Ave Minneapolis, MN
    612-822-4611

Open Daily: 10am - 10pm | Alley-side Pickup: 10am - 7pm
3038 Hennepin Ave Minneapolis, MN
612-822-4611
Medical Device Regulation: Fda-Cdrh Manufacturing, Policies and Regulation Handbook

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

Wreh, Elijah

Paperback

Technology & Engineering

ISBN10: 0323953549
ISBN13: 9780323953542
Publisher: Academic Press
Published: Feb 24 2023
Pages: 678
Weight: 2.53
Height: 1.36 Width: 7.50 Depth: 9.25
Language: English
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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