Английски език
Medical Device Regulations is a handbook on FDA-CDRH current thinking on regulation of medical devices. This book provides information on how devices are determined to meet criteria for being a medical device, what agencies regulate medical devices, how policies regarding regulation affect the market, rules regarding marketing, and laws and standards that govern testing. This book helps medical device manufacturers both in and out of the United States with premarket application and meeting FDA complex regulatory requirements.Continuous development of medical devices and the associated regulatory affairs is a complex and ever-changing field; this practical, well-structured reference tool will be useful to many professionals in this area. Includes practice exam questions for regulatory affairs certification. This book offers a large and comprehensive overview of the field, and the author has expertise in regulatory affairs and commercialization of medical devices. 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
