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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
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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
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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