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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
ISO 13485:2016
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Summary: This book provides valuable, effective guidance for understanding, interpreting and implementing ISO 13485:2016 standard requirements. Despite its more
Developing an ISO 13485-Certified Quality Management System
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This book details the lessons learned from a real-world project focusing on building an ISO 13485:2016 Quality Management System (QMS) from scratch and then hav
A Practical Field Guide for ISO 13485:2016
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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
The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices
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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