Guideline

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Guide to Inspections of Quality Systems
Internet:	http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074883.htm
Origin/Publisher:	FDA http://www.fda.gov/ora/inspect_ref/igs/qsit/QSITGUIDE.PDF
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 and related regulations.
Status:	Guide to Inspections