An edition of ISO 13485 (2011)

ISO 13485

a complete guide to quality management in the medical device industry

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  • 2 Want to read
Cover of: ISO 13485 by Itay Abuhav, Itay Abuhav
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Last edited by MARC Bot
September 16, 2024 | History
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An edition of ISO 13485 (2011)

ISO 13485

a complete guide to quality management in the medical device industry

by

  • 2 Want to read

"The United States and European Union now require the ISO 13485 Standard certification for medical device manufacturers. Written by an experienced industry professional, this practical book provides a complete guide to the ISO 13485 standard certification for medical device manufacturing in terms of quality control. It covers all the requirements of ISO 13485 and offers a step-by-step comparison between the ISO 13485 and ISO 9001, enabling a sound understanding of these new procedures"--Provided by publisher.

Publish Date
Publisher
Taylor & Francis, CRC Press
Language
English
Pages
361

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Previews available in: English

Subjects

Medical instruments and apparatus, Medical instruments and apparatus industry, Equipment Design, Manufactured Materials, Handbooks, manuals, Standards, Equipment and Supplies, Quality control, Quality control, standards, Manufacturing processes, Qualité, Guides, manuels, Contrôle, Médecine, Appareils et instruments, Industrie, Normes, BUSINESS & ECONOMICS, Industries, General, BUSINESS & ECONOMICS / Industries / General, MEDICAL, Instruments & Supplies
Edition Availability
Cover of: ISO 13485
ISO 13485
2018, Taylor & Francis Group, CRC Press
in English
Cover of: ISO 13485
ISO 13485: A Complete Guide to Quality Management in the Medical Device Industry
2017, Taylor & Francis Group
in English
Cover of: ISO 13485
ISO 13485: a Complete Guide to Quality Management in the Medical Device Industry
2012, Taylor & Francis Group
in English
Cover of: ISO 13485
ISO 13485: a complete guide to quality management in the medical device industry
2012, Taylor & Francis, CRC Press
in English
Cover of: ISO 13485
ISO 13485: A Complete Guide to Quality Management in the Medical Device Industry
2011, Taylor & Francis Group
in English

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Book Details

Table of Contents

Scope
Normative references
Terms and definitions
Quality management system
Management responsibility
Resource management
Product realization
Measurement, analysis, and improvement.

Edition Notes

Includes bibliographical references and index.

Published in
Boca Raton

Classifications

Dewey Decimal Class
610.284
Library of Congress
R856.15 .A28 2012, R856.6, R856.15 .A28 2012eb

The Physical Object

Pagination
p. ;
Number of pages
361

ID Numbers

Open Library
OL24906439M
Internet Archive
iso13485complete0000abuh
ISBN 13
9781439866115
LCCN
2011022826
OCLC/WorldCat
763161406, 728458299

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September 16, 2024 Edited by MARC Bot import existing book
March 19, 2023 Edited by ImportBot import existing book
December 15, 2022 Edited by MARC Bot import existing book
December 12, 2022 Edited by MARC Bot import existing book
July 30, 2011 Created by LC Bot import new book