The FDA QSR requires device manufacturers to validate processes when the manufacturer cannot "fully verify the output". The manufacturer must validate these processes with a "high degree of assurance".
Medical Device Process Validation - Statistical Aspects - Webinar By GlobalCompliancePanel
2 May 2012, Wilmington, United States
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OnlineTraining
OnlineTraining, 1000 N West Street, DE, Suite 1200, Wilmington, 19801, United States
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