Validation for Medical Device and Diagnostic Manufacturers (Hardcover) (ISBN-13: 9781574910636)

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 must demonstrate that product design, process, and test methods/requirements/specifications determined during development can be met in the environment of intended use. This book provides practical guidance on how to develop and validate product designs, manufacturing processes, and test methods that comply with the requirements of QSR.

Author: Carol V. Desain, Charmaine V. Sutton
ISBN-10: 1574910639
ISBN-13: 9781574910636
Publisher: CRC Press
Language: English
Published: 09/30/1997
Pages: 336
Format: Hardcover
Weight: 1.44lbs
Size: 9.44h x 6.00w x 0.91d