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ISO 13485 : a complete guide to quality management in the medical device industry

Author: Itay Abuhav
Publisher: Boca Raton : CRC Press, ©2012.
Edition/Format:   Print book : EnglishView all editions and formats
Summary:
"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  Read more...
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Genre/Form: Handbooks, manuals, etc
Material Type: Internet resource
Document Type: Book, Internet Resource
All Authors / Contributors: Itay Abuhav
ISBN: 9781439866115 1439866112
OCLC Number: 728458299
Notes: Includes index.
Description: xi, 361 pages : illustrations ; 24 cm
Contents: Scope --
Normative references --
Terms and definitions --
Quality management system --
Management responsibility --
Resource management --
Product realization --
Measurement, analysis, and improvement.
Responsibility: Itay Abuhav.

Abstract:

"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.

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