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Developing an ISO 13485-Certified Quality Management System
sidottu,
2022,
englanti,
ISBN 9781032065748
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 …
Medical-Grade Software Development
sidottu,
2023,
englanti,
ISBN 9781032593180
This book is a practical guide to meeting IEC 62304 software-development requirements within the context of an ISO 13485 quality management system (QMS). The book proves this can …