The RAPS learning platform provider will be upgrading its security posture. This will take the system off-line from 20 July through the end of the day 23 July. This will affect any Online Course, eBook, and Virtual Program Attendance. Thank you for your patience.
Internal IVD Audit: Readiness for an FDA Inspection
Posted 01 May 2011 | By
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.