Validation for Medical Device and Diagnostic Manufacturers

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Validation for Medical Device and...

Validation for Medical Device and Diagnostic Manufacturers

Name: Validation for Medical Device and Diagnostic Manufacturers
ISBN: 9781574910636

Carol V. Desain (Author), Charmaine V. Sutton (Author)

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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

درجه (قاطیغوری(:

Medicine

کال:

1997

خپرونه:

خپرندویه اداره:

CRC Press

ژبه:

english

ISBN 10:

1574910639

ISBN 13: