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Medical Device Software Verification, Validation and Compliance
Language: en
Pages: 445
Authors: David A. Vogel
Categories: Medical
Type: BOOK - Published: 2011 - Publisher: Artech House

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HereOCOs the first book written specifically to help medical device and software engineers, QA and compliance professionals, and corporate business managers bet
Pharmaceutical Computer Systems Validation
Language: en
Pages: 773
Authors: Guy Wingate
Categories: Medical
Type: BOOK - Published: 2016-04-19 - Publisher: CRC Press

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Thoroughly revised to include the latest industry developments, the Second Edition presents a comprehensive overview of computer validation and verification pri
Software Testing Basics
Language: en
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Authors: Paul Felten
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Type: BOOK - Published: 2017-03-08 - Publisher: Createspace Independent Publishing Platform

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Software Testing Basics contains the necessary software verification fundamentals for dedicated testers in the medical device industry. The methods and concepts
Pharmaceutical and Medical Devices Manufacturing Computer Systems Validation
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Authors: Orlando Lopez
Categories: Business & Economics
Type: BOOK - Published: 2018-10-02 - Publisher: Taylor & Francis

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Validation of computer systems is the process that assures the formal assessment and report of quality and performance measures for all the life-cycle stages of
DESIGN CONTROLS, RISK MANAGEMENT & PROCESS VALIDATION FOR MEDICAL DEVICE PROFESSIONALS
Language: en
Pages: 441
Authors: Vernon Geckler
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Type: BOOK - Published: 2017-02-11 - Publisher: Wasatch Consulting Resources LLC

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This handbook provides the most up to date resource currently available for interpreting and understanding design controls. This handbook is the most exhaustive