ISO14971:2019istheinternationalstandardfortheapplicationofriskmanagementtomedicaldevices.Thehigh-definition(HD)versionofISO14971:2019providesaclearandenhanceddigitalcopyoftheoriginaldocument,ensuringbetterreadabilityandusabilityforprofessionalsinthemedicaldeviceindustry.Thisversionmaintainsalltheoriginalcontent,includingtheprinciples,framework,andprocessesforriskmanagement,whileofferingimprovedvisualqualityforon-screenviewingandprinting.Thestandardoutlinesrequirementsforidentifyinghazards,estimatingandevaluatingrisks,controllingrisks,andmonitoringtheeffectivenessofriskcontrolmeasuresthroughoutthelifecycleofamedicaldevice.TheHDversionisparticularlyusefulforregulatorycompliance,training,andreferencepurposes,asitallowsforeasiernavigationandannotation.Itisessentialformanufacturers,regulatoryprofessionals,andqualityassuranceteamstoensurethesafetyandefficacyofmedicaldevicesinaccordancewithglobalregulatoryexpectations.
