The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a hyperlink.
FDA Guide to Inspections of Quality Systems (08/99)
Origin/Publisher:
FDA, ORA, CDRH
Document Type:
FDA Guide to Inspection
Content:
This document provides guidance to the FDA field staff on a new inspectional process that may be used to assess a medical device manufacturer`s compliance with the Quality System regulation
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