Validation for Medical Device and Diagnostic Manufacturers

by Carol DeSain and Charmaine Vercimak Sutton

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...

• Format: Hardcover
• Language: English
• ISBN: 0935184643
• ISBN13: 9780935184648
• Release Date: January 1994
• Publisher: Informa Medical
• Length: 301 Pages
• Weight: 1.50 lbs.

Customer Reviews

Excellent

Excellent book. Easy to read and understand for the basics of verification and validation throughout the product lifecycle.