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Validation for Medical Device and Diagnostic Manufacturers

Language EnglishEnglish
Book Hardback
Book Validation for Medical Device and Diagnostic Manufacturers Carol V. Desain
Libristo code: 13936067
Publishers Taylor & Francis Inc, September 1997
Implementation of FDA's Design Control requirements (21 CFR 820.30) changed an entire industry. Qual... Full description
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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.

About the book

Full name Validation for Medical Device and Diagnostic Manufacturers
Author Carol V. Desain, Charmaine V. Sutton
Language English
Binding Book - Hardback
Date of issue 1997
Number of pages 336
EAN 9781574910636
ISBN 1574910639
Libristo code 13936067
Publishers Taylor & Francis Inc
Weight 658
Dimensions 152 x 229 x 23

Categories

Medicine & Nursing > Medicine: general issues > Medical equipment & techniques
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