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Medical Device Quality Management Systems
Language: en
Pages: 0
Authors: Susanne Manz
Categories: Science
Type: BOOK - Published: 2018-10-02 - Publisher: Academic Press

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Medical Devices Quality Management Systems: Strategy and Techniques for Improving Efficiency and Effectiveness is written for the needs of quality, compliance,
ISO 13485:2016
Language: en
Pages: 735
Authors: Itay Abuhav
Categories: Medical
Type: BOOK - Published: 2018-05-11 - Publisher: CRC Press

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Summary: This book provides valuable, effective guidance for understanding, interpreting and implementing ISO 13485:2016 standard requirements. Despite its more
Medical Device Quality Management Systems
Language: en
Pages: 298
Authors: Susanne Manz
Categories: Science
Type: BOOK - Published: 2018-09-27 - Publisher: Academic Press

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Medical Devices Quality Management Systems: Strategy and Techniques for Improving Efficiency and Effectiveness is written for the needs of quality, compliance,
Developing an ISO 13485-Certified Quality Management System
Language: en
Pages: 331
Authors: Ilkka Juuso
Categories: Business & Economics
Type: BOOK - Published: 2022-03-20 - Publisher: CRC Press

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Developing an ISO 13485-Certified Quality Management System: An Implementation Guide for the Medical-Device Industry details the lessons learned from a real-wor
The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices
Language: en
Pages: 355
Authors: Amiram Daniel
Categories: Medical
Type: BOOK - Published: 2008-01-01 - Publisher: Quality Press

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How have recent changes in domestic and international regulations affected quality management in the development and marketing of medical devices in the US and