Validation for Medical Device and Diagnostic Manufacturers

By Carol De Sain, Carol V. Desain, Charmaine V. Sutton

Book Overview

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,... This description may be from another edition of this product.

• Format: Hardcover
• Language: English
• ISBN: 1574910639
• ISBN13: 9781574910636
• Release Date: November 1997
• Publisher: CRC Press
• Length: 336 Pages
• Weight: 1.45 lbs.
• Dimensions: 0.9" x 6.0" x 9.4"