eBook - ePub

ISO 13485:2016

Name: ISO 13485:2016
ISBN: 9781351000772

A Complete Guide to Quality Management in the Medical Device Industry, Second Edition

Itay Abuhav,

878 pages
English
ePUB (mobile friendly)
Available on iOS & Android

eBook - ePub

ISO 13485:2016

A Complete Guide to Quality Management in the Medical Device Industry, Second Edition

Itay Abuhav,

About this book

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 author's 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:

A pragmatic and down to earth approach towards the reader's understanding of ISO 13485:2016 standard requirements implementation.
Uses examples and cases from real-life based on the author's many years of experience in quality management.
A table of contents structured identically to that of ISO 13485:2016 itself, allowing easier navigation and orientation for the reader.
Emphasises guidance for ISO 13495:2016 standard requirements which are difficult to interpret and implement
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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Yes, you can access ISO 13485:2016 by Itay Abuhav in PDF and/or ePUB format, as well as other popular books in Technik & Maschinenbau & Biotechnologie in der Medizin. We have over one million books available in our catalogue for you to explore.