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1. Medical Device Quality Systems Manual

HHS Publication FDA 97 4179 MEDICAL DEVICE QUALITY SYSTEMS MANUAL A SMALL ENTITY COMPLIANCE GUIDE First Edition Supersedes the Medical Device Good Manufacturing Practices Manual Andrew Lowery Judy Strojny and Joseph Puleo Division of Small Manufacturers Assistance Office of Health and Industry Programs CENTER FOR DEVICES AND RADIOLOGICAL HEALTH CDRH December 1996 This publication supersedes FDA 91 4179 U S DEPARTMENT OF HEALTH AND HUMAN SERVICES Publi
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