ENISO14155-2020isaninternationalstandardthatprovidesguidelinesfortheconductofclinicalinvestigationsofmedicaldevicesinhumansubjects.Itoutlinestheethicalprinciples,methodology,andrequirementsforplanning,conducting,recording,andreportingclinicalinvestigationstoensurethesafety,well-being,andrightsofparticipantsareprotected.Thestandardappliestoallstagesoftheclinicalinvestigation,frominitialdesigntofinalreporting,andisintendedtoproducereliableandscientificallyvaliddata.CompliancewithENISO14155-2020helpsmanufacturersandinvestigatorsmeetregulatoryrequirementsinvariousjurisdictions,ensuringthatmedicaldevicesareevaluatedinaconsistentandethicalmanner.Thestandardalsoemphasizesriskmanagement,dataintegrity,andtheimportanceofinformedconsentthroughouttheclinicalinvestigationprocess.
