The FDA and worldwide quality system requirements guidebook for medical devices

The FDA and worldwide quality system requirements guidebook for medical devices /

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"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...

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Bibliographic Details
Main Author: Daniel, Amiram
Other Authors: Kimmelman, Ed, Trautman, Kimberly A., 1964-
Format: Electronic eBook
Language:English
Published: Milwaukee, Wis. : ASQ Quality Press, 2008.
Edition:2nd ed.
Subjects:
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.
Quality control.
Device Approval > legislation & jurisprudence
Equipment and Supplies > standards
Equipment Safety > standards
Government Regulation
Guidelines as Topic
Quality Control
quality control.
United States
Guideline
Online Access:Full text (Emerson users only)
Full text (Emmanuel users only)
Full text (MCPHS users only)
Full text (Wentworth users only)
Description
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
Item Description:Includes index.
Revised edition of: FDA and worldwide quality system requirements guide book for medical devices / Kimberly A. Trautman. ©1997.
Physical Description:1 online resource (xxx, 304 pages)
ISBN:9781621982067
1621982068

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