Validation for Medical Device and Diagnostic Manufacturers

ISBN: 9781574910636 出版年：1997 页码：333 Desain, Carol V Sutton, Charmaine V CRC Press

Implementation of FDA's Design Control requirements (21 CFR 820.30) changed an entire industry. Quality System Requirements defined the approach to medical device validation. Product design, manufacturing process, and test method validation studies must be performed before or as a product is transferred to commercial production. Validation studies