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This book details the lessons learned from a real-world project focusing on building... Læs mere
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This book is a practical guide to meeting IEC 62304 software development requirements within the context of an ISO 13485 quality management system (QMS). It proves it can be done with a minimum amount of friction, overlap, and back-and-forth between development stages.
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This book simplifies the process regarding the application of usability to medical devices for new developers by providing a thought-out walkthrough of what is involved and how the expectations from the essential standards affect their work and why.