The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices

Front Cover
ASQC Quality Press, 1997 - Law - 210 pages
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This book provides essential information regarding the new FDA regulation for medical devices and international quality system requirements (ISO 9001 and ISO/DIS 13485:1996). Icons quickly establish the differences and relationship between FDA regulation, the ISO 9001 standard, FDA guidance, and the Global Harmonization Task Force (GHTF) guidance. In addition, the end of each subsection includes blank pages for your notes. This book allows manufacturers to establish a single quality system that satisfies world requirements.

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Contents

Introduction
1
SUBPART
3
SUBPART A General Provisions
15
Copyright

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