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A Practical Field Guide for ISO 13485:2016
Language: en
Pages: 252
Authors: Erik V. Myhrberg
Categories: Business & Economics
Type: BOOK - Published: 2019-11-06 - Publisher: Quality Press

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The purpose of this expanded field guide is to assist organizations, step-by-step, in implementing a quality management system (QMS) in conformance with ISO 134
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
The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices
Language: en
Pages: 338
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
ISO 13485
Language: en
Pages: 376
Authors: Itay Abuhav
Categories: Medical
Type: BOOK - Published: 2011-10-20 - Publisher: CRC Press

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Although complex and lengthy, the process of certification for the ISO 13485 can be easily mastered using the simple method outlined in ISO 13485: A Complete Gu
A Practical Field Guide for ISO 14001:2015
Language: en
Pages: 104
Authors: Erik V. Myhrberg
Categories: Business & Economics
Type: BOOK - Published: 2017-01-01 - Publisher: Quality Press

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The field guide depicts step by step what must occur for organizations to create an effective environmental management system (EMS) in conformance with ISO 1400
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