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Test Method Validation for Medical Devices
Language: en
Pages: 62
Authors: Emmet Tobin
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Type: BOOK - Published: 2017-07-25 - Publisher: Createspace Independent Publishing Platform

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This concise book fits right in the Engineers pocket. It provides a brief introduction to Test method validation and is a useful resource that defines key terms
Validation for Medical Device and Diagnostic Manufacturers
Language: en
Pages: 340
Authors: Carol V. Desain
Categories: Medical
Type: BOOK - Published: 1997-09-30 - Publisher: CRC Press

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Implementation of FDA's Design Control requirements (21 CFR 820.30) changed an entire industry. Quality System Requirements defined the approach to medical devi
Medical Device Software Verification, Validation and Compliance
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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
Statistical Procedures for the Medical Device Industry
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Process Validation for Medical Devices
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Authors: Emmet Tobin, Mr.
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Type: BOOK - Published: 2017-09-29 - Publisher: Createspace Independent Publishing Platform

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At over 200 pages, this pocket book will bring you up to speed quickly on the requirements of process validation. It is divided into logical chapters that sets