Validation for Medical Device and Diagnostic Manufacturers

£220.00

Validation for Medical Device and Diagnostic Manufacturers

Science: general issues Biology, life sciences Pharmaceutical chemistry and technology

Authors: Carol V. Desain, Charmaine V. Sutton

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Language: English

Published by: CRC Press

Published on: 30th September 1997

Format: LCP-protected ePub

ISBN: 9781040204382


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

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