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Developing an ISO 13485-Certified Quality Management System: An Implementation Guide for the Medical-Device Industry

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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-world project focusing on building an ISO 13485:2016 Quality Management System (QMS) from scratch and then having it officially certified. It is a practical guide to building or improving your existing QMS with tried and tested solutions.

The book takes a hands-on approach–first teaching the top 25 lessons to know before starting to dev...