£191.31

CRC Press Validation for Medical Device and Diagnostic Manufacturers

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Last 378 days • 378 data points (No recent data available)

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£197.22 £154.96 £164.18 £173.40 £182.62 £191.84 £201.06 01 January 2025 05 April 2025 08 July 2025 10 October 2025 13 January 2026

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42 days 15 days 11 days 27 days 68 days 23 days 2 days 114 days · current 59 days · current 17 days 0 29 57 86 114 £159 £161 £175 £176 £178 £187 £189 £191 £192 £197 Days at Price

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Most common price: £191 (114 days, 30.2%)

Price range: £159 - £197

Price levels: 10 different prices over 378 days

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

Format
Hardcover
Domain
Amazon UK
Release Date
11 November 1997
Listed Since
18 December 2006

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