ISO 13485
a complete guide to quality management in the medical device industry
By Itay Abuhav
"ISO 13485" is published by Taylor & Francis in 2012 - Boca Raton, it has 361 pages and the language of the book is English.
“ISO 13485” Metadata:
- Title: ISO 13485
- Author: Itay Abuhav
- Language: English
- Number of Pages: 361
- Publisher: Taylor & Francis
- Publish Date: 2012
- Publish Location: Boca Raton
“ISO 13485” Subjects and Themes:
- 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 Specifications:
- Pagination: p. ;
Edition Identifiers:
- The Open Library ID: OL24906439M - OL16002258W
- Online Computer Library Center (OCLC) ID: 763161406 - 728458299
- Library of Congress Control Number (LCCN): 2011022826
- ISBN-13: 9781439866115
- All ISBNs: 9781439866115
AI-generated Review of “ISO 13485”:
"ISO 13485" Table Of Contents:
- 1- Scope
- 2- Normative references
- 3- Terms and definitions
- 4- Quality management system
- 5- Management responsibility
- 6- Resource management
- 7- Product realization
- 8- Measurement, analysis, and improvement.
"ISO 13485" Description:
The Open Library:
"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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