ENISO14971-2012istheinternationalstandardfortheapplicationofriskmanagementtomedicaldevices.Itprovidesaframeworkformanufacturerstoidentifyhazards,estimateandevaluateassociatedrisks,controltheserisks,andmonitortheeffectivenessofthecontrolsthroughoutthelifecycleofthedevice.Thestandardemphasizesaproactiveapproachtoriskmanagement,ensuringthatpotentialharmsareaddressedbeforetheycanaffectpatients,users,orothers.CompliancewithENISO14971-2012isessentialformeetingregulatoryrequirementsinmanyjurisdictions,includingtheEuropeanUnion,whereitisharmonizedundertheMedicalDevicesRegulation(MDR)andInVitroDiagnosticRegulation(IVDR).Thehigh-definitionversionofthestandardoffersimprovedreadabilityoftext,diagrams,andtables,facilitatingbetterunderstandingandimplementationofriskmanagementprocesses.
