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£204.69

CRC Press Validation for Medical Device and Diagnostic Manufacturers

Name: Validation for Medical Device and Diagnostic Manufacturers
Brand: CRC Press
Price: 204.69 GBP
Availability: InStock

Biological Sciences

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Description

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.

Product Specifications

Brand: CRC Press
Format: hardcover
ASIN: 1574910639
Category: Books > Subjects > Science, Nature & Maths > Biological Sciences
Domain: Amazon UK
Release Date: 11 November 1997
Listed Since: 18 December 2006

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CRC Press Validation for Medical Device and Diagnostic Manufacturers

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