ENISO14971-2012isaninternationalstandardthatprovidesguidelinesfortheapplicationofriskmanagementtomedicaldevices.Itoutlinesasystematicprocessforidentifyinghazards,estimatingandevaluatingassociatedrisks,controllingtheserisks,andmonitoringtheeffectivenessofthecontrols.Thestandardisintendedtoensurethesafetyofmedicaldevicesthroughouttheirentirelifecycle,fromdesignanddevelopmenttoproduction,post-production,anddecommissioning.Itemphasizestheimportanceofariskmanagementplan,riskanalysis,riskevaluation,riskcontrol,andoverallriskmanagementreview.CompliancewithENISO14971-2012helpsmanufacturersmeetregulatoryrequirementsanddemonstrateduediligenceinaddressingpotentialrisksassociatedwiththeirmedicaldevices.ThestandardisharmonizedwithEuropeanmedicaldevicedirectives,makingitacriticalcomponentformarketaccessintheEuropeanUnion.
