ISOTR20416:2020providesguidanceformanufacturersonpost-marketsurveillanceofmedicaldevices.Itoutlinesasystematicprocesstoproactivelycollectandreviewexperiencegainedfromdevicesonthemarket,toidentifyanyneedforcorrectiveorpreventiveactions.Thestandardcoversrequirementsforestablishingapost-marketsurveillancesystem,includingprocessesforcollectingdata,analyzinginformation,andmaintainingrecords.Itemphasizestheimportanceofcontinuousmonitoringthroughouttheentireproductlifecycletoensureongoingsafetyandperformanceofmedicaldevices.Thedocumentalsoaddressestherelationshipbetweenpost-marketsurveillanceandotherqualitymanagementsystemprocesses,aswellasregulatoryreportingobligations.With51pagesofcomprehensiveguidance,itservesasavaluableresourceformedicaldevicemanufacturerstomeetglobalregulatoryexpectationsforpost-marketsurveillanceactivities.
