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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 authors many years of experience in consulting to illustrate even the most complex of ISO 13485:2016 standard requirements and their implementation. Identifying relevant requirements and how they harmonize with quality management systems, developing processes for design and development, as well as product realization and validation are just a few of the issues covered in-depth by this publication.
In addition, the author constantly reviews the distinctive characteristics and aspects of the medical device manufacturing industry, so that the reader can also appreciate the subject of this book in an everyday context.
Features:
- Constantly reviews the aspect of medical device industry characteristics and distinctive so the reader can reflect the content with its daily work.
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