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ISO 13485:2016

Name: ISO 13485:2016
Brand: Taylor & Francis Ltd
SKU: 18775059
Price: 271.89 EUR
Availability: InStock
Author: ABUHAV
ISBN: 9781138039179

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

ABUHAV

Lingua

Inglese

Libro Rigido

Codice Libristo: 18775059

Casa editrice Taylor & Francis Ltd, maggio 2018

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

Codice Libristo: 18775059

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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:

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.

Attrice & Poliglotta

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Informazioni sul libro

Titolo completo ISO 13485:2016

Autore ABUHAV

Lingua

Inglese

Rilegatura Libro - Rigido

Data di pubblicazione 2018

Numero di pagine 878

EAN 9781138039179

ISBN 9781138039179

Codice Libristo 18775059

Casa editrice Taylor & Francis Ltd

Peso 1612

Dimensioni 241 x 161 x 50

Categorie

Economia, Finanza, Imprenditoria e Management > Economia Aziendale, Imprenditoria e Management > Management e tecniche gestionali > Gestione di settori specifici > Gestione della produzione e controllo qualità

Economia, Finanza, Imprenditoria e Management > Studi sui settori produttivi e manifatturieri > Industrie manifatturierie

Medicina e Infermieristica > Medicina: argomenti di interesse generale > Attrezzature e tecniche mediche