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Medical Device Post Market Surveillance

Proactive PMSReactive PMS
Review of Product QualityTesting & Lot verificationPeriodic Risk AssessmentSurveying CustomersClinical trials prior to CE marking, inclusive of PMCFDevice tracking/ implant registries sponsored by manufacturer.Focus groups (Expert users)Complaints from customersVoluntary user feedback(apart from complaints)Reports of maintenance and service.Routine in-house testingAnalysis of failuresThrough social media and literature reviewsTrials sponsored by non-manufacturers