Medical Device Regulation: FDA-CDRH Manufacturing, Policies and Regulation Handbook
Elijah Wreh, B0BWTTKB1H, 0323953549, 0323953530, 9780323953535, 978-0323953535, 9780323953542, 978-0323953542, 978-0-323-95354-2
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.
- Offers a unique focus on the regulatory affairs industry, specifically targeted at regulatory affairs professionals and those seeking certification
- Puts regulations in the context of contemporary design
- Includes case studies and applications of regulations