Internal IVD Audit: Readiness for an FDA Inspection

Posted 01 May 2011 | By Ron Schoengold, RAC 

In 1997, the US Food and Drug Administration (FDA) began using the Quality System Inspections Technique (QSIT) at medical device manufacturers to improve utilization of its limited field support resources and investigators. This "top-down" system of inspection provides guidance for medical device manufacturers on their state of compliance with the Quality System Regulation (QSR) (21 CFR Part 820) and related regulations.

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