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The FDA and Worldwide Quality System Requirements Guidebook for Medical
Devices
Compiled by Kimberly A. Trautman
Publisher: American Society for Quality Control (ASQC)
Copyright: 1996
ISBN:0-87389-377-8
Price: ASQC Member Price US$36.00; List Price: US$40.00
Page Count: 210 pages
Kimberly Trautman is a GMP/Quality Systems Expert for the Office of Compliance
Center for Devices and Radiological Health at the U.S. Food and Drug Administration
(FDA). Her book provides essential information regarding the new FDA regulation
for medical devices and two key international quality systems requirements,
ISO 9001 and ISO/DIS 13485. The differences and relationships between the
FDA regulation, the ISO 9001 standard, FDA guidance, and the Global Harmonization
Task Force (GHTF) guidance are established. The book is designed to allow
manufacturers to establish a single quality system that satisfies world
requirements.
To order, or for more information, contact:
ASQC, P.O. Box 3005, Milwaukee, WI 53201-3005 USA
Telephone: +1 800-248-1946 Outside the US, call +1 414-272-8575
Facsimile: +1 414-272-1734
Internet: http://www.asqc.org
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