Download or read book Validation for Medical Device and Diagnostic Manufacturers written by Carol V. Desain and published by CRC Press. This book was released on 1997-09-30 with total page 340 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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