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ISO 13485:2016

Name: ISO 13485:2016
Brand: Taylor & Francis Ltd
SKU: 9781138039179
Price: 1337.42 RON
Availability: InStock

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

Autor: ABUHAV

Limbă:

Legare: Copertă tare

Editura: Taylor & Francis Ltd

Disponibilitate: șansă 50%

Şanse de a obține acest titlu

1 337.42 lei

Summary:This book provides valuable, effective guidance for understanding, interpreting and implemen...

Informații despre carte

Autor

ABUHAV

Limbă

engleză

Legare

Carte - Copertă tare

Publicat

2018

Pagini

878

EAN

9781138039179

ISBN

9781138039179

Enbook ID

18775059

Editura

Taylor & Francis Ltd

Greutate

1612

Dimensiuni

241 x 161 x 50

Descriere completă

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:

A pragmatic and down to earth approach towards the readers understanding of ISO 13485:2016 standard requirements implementation.

Uses examples and cases from real-life based on the authors 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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ISO 13485:2016

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

Informații despre carte

Descriere completă

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