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ISO 13485:2016: A Complete Guide to Quality Management in the Medical Device Industry, Second Edition

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Summary:

This book provides valuable, effective guidance for understanding, interpreting and implementing ISO 13485:2016 standard requirements. Despite its more than 800-page length, the author has specifically designed its contents to maximize usability for the reader with a table of contents identical to that of the ISO standard itself, which enables easy navigation and orientation.

Pragmatic in style and down to earth in tone, this book draws real-life examples and case-studies from the au...