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Validation for Medical Device and Diagnostic Manufacturers | 2 Edition

Authors: Desain, Carol V.,Sutton, Charmaine V.

ISBN:1574910639
ISBN-13: 9781574910636

List Price: $240.00 (up to 69% savings)

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Buy Used $75.20 Buy New $207.00

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eTextbook $154.00

Rent $42.65 Buy Used $74.40

Details about Validation for Medical Device and Diagnostic Manufacturers:

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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