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Validation for Medical Device and Diagnostic Manufacturers

Validation for Medical Device and Diagnostic Manufacturers

by Desain, Carol V
No customer reviews yet ISBN 9781574910636 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 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.

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BrandCRC Press
Pub dateSep 30, 1997
ISBN-101574910639
ISBN-139781574910636
Hardcover336.0 pages
LanguageEnglish
Dimensions9 × 0.95 × 6 in
Weight1 lb
Last updated 2026-07-29 02:13
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