Research Catalog

The FDA and worldwide quality system requirements guidebook for medical devices / compiled and written by Amiram Daniel & Ed Kimmelman.

Title
The FDA and worldwide quality system requirements guidebook for medical devices / compiled and written by Amiram Daniel & Ed Kimmelman.
Author
Daniel, Amiram.
Publication
Milwaukee, Wis. : ASQ Quality Press, 2008.

Holdings

Details

Additional Authors
  • Kimmelman, Ed.
  • Trautman, Kimberly A., 1964-
Description
xxx, 304 p. : ill.; 24 cm.
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.
Subject
  • Device Approval > legislation & jurisprudence
  • Equipment Safety > standards
  • Equipment and Supplies > standards
  • Government Regulation
  • Guidelines as Topic
  • 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
  • Quality control > Law and legislation > United States
  • Quality control > Law and legislation
  • United States
Genre/Form
Guideline
Note
  • Includes index.
  • Rev. ed. of: FDA and worldwide quality system requirements guide book for medical devices / Kimberly A. Trautman. c1997.
Processing Action (note)
  • committed to retain
ISBN
  • 9780873897402 (alk. paper)
  • 0873897404 (alk. paper)
LCCN
^^2008013052