Medical Device Regulation

FDA-CDRH Manufacturing, Policies and Regulation Handbook

von Elijah Wreh

680 Seiten, Taschenbuch

Kurzbeschreibung des Verlags

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.

• Reihe: Academic Press
• ISBN: 9780323953542
• Sprache: Englisch
• Erscheinungsdatum: 24.02.2023
• Größe: 235 x 191 mm
• Verlag: Elsevier Inc