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Book Cover
E-book
Author Daniel, Amiram.

Title The FDA and worldwide quality system requirements guidebook for medical devices / compiled and written by Amiram Daniel & Ed Kimmelman
Edition Second edition
Published Milwaukee, Wis. : ASQ Quality Press, 2008
Online access available from:
ProQuest Ebook Central Subscription Collection    View Resource Record  
Knovel    View Resource Record  

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Description 1 online resource (xxx, 304 pages)
Summary "This new and expanded second edition maintains the organizational approach of the first and includes the requirements and guidance contained in the Quality System Regulation (QSReg), the ISO 13485:2003 standard, and the ISO/TR 14969:2004 guidance document, and, as appropriate, a number of the FDA and Global Harmonization Task Force (GHTF) guidance documents." "This second edition also addresses a number of additional topics, such as the incorporation of risk management into the medical device organization's QMS, QMS issues related to continuation products, the key process interactions within a QMS, effective presentation of and advocacy for a QMS during FDA inspections and third-party assessments, and future FDA compliance and standards activities."--Jacket
Notes Includes index
Revised edition of: FDA and worldwide quality system requirements guide book for medical devices / Kimberly A. Trautman. c1997
Print version record
Subject Device Approval -- legislation & jurisprudence.
Equipment and Supplies -- standards.
Equipment Safety -- standards.
Government Regulation.
Guidelines as Topic.
Quality Control.
Medical instruments and apparatus industry -- Law and legislation -- United States.
Medical instruments and apparatus industry -- Law and legislation.
Medical instruments and apparatus industry -- Quality control.
Medical instruments and apparatus industry -- United States -- Quality control.
Quality control -- Law and legislation -- United States.
Quality control -- Law and legislation.
United States.
Genre/Form Guideline.
Form Electronic book
Author Kimmelman, Ed.
Trautman, Kimberly A., 1964- FDA and worldwide quality system requirements guide book for medical devices
ISBN 1621982068 (electronic bk.)
9781621982067 (electronic bk.)