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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 2nd ed
Published Milwaukee, Wis. : ASQ Quality Press, 2008

Copies

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 Umschulungswerkstätten für Siedler und Auswanderer Bitterfeld gnd
Subject Medical instruments and apparatus industry -- Law and legislation -- United States
Quality control -- Law and legislation -- United States
Medical instruments and apparatus industry -- United States -- Quality control
Medical instruments and apparatus industry -- Law and legislation
Quality control -- Law and legislation.
Medical instruments and apparatus industry -- Quality control
Device Approval -- legislation & jurisprudence
Equipment and Supplies -- standards
Equipment Safety -- standards
Government Regulation
Guidelines as Topic
Equipment and Supplies -- standards -- United States -- Guideline
Guidelines as Topic -- United States -- Guideline
Device Approval -- legislation & jurisprudence -- United States -- Guideline
Government Regulation -- United States -- Guideline
Quality Control -- United States -- Guideline
Equipment Safety -- standards -- United States -- Guideline
Medical instruments and apparatus industry -- Law and legislation
Medical instruments and apparatus industry -- Quality control
Quality control -- Law and legislation
Medizinisches Gerät
Qualitätskontrolle
United States
USA
Form Electronic book
Author Kimmelman, Ed
Trautman, Kimberly A., 1964- FDA and worldwide quality system requirements guide book for medical devices
ISBN 9781621982067
1621982068