Medical_Device_Risk_Management_Using_ISO_14971

RiskManagement-ISO149711OmbuEnterprises,LLCDanO’LearyPresidentOmbuEnterprises,[e-mail]•DanO’Leary–DanO’LearyisPresidentofOmbuEnterprises,LLC,aneducation,training,andconsultingcompanyfocusingonOperationalExcellenceusinganalyticalskillsandasystemsapproachtooperationsmanagement.–Danhasmorethan30yearsexperienceinquality,operations,andprogrammanagementinregulatedindustriesincludingaviation,defense,medicaldevices,andclinicallabs.–HeholdsaMastersDegreeinMathematics;isanASQcertifiedBiomedicalAuditor,QualityAuditor,QualityEngineer,ReliabilityEngineer,andSixSigmaBlackBelt;andiscertifiedbyAPICSinResourceManagement.•OmbuEnterprises,LLC–Ombuworkswithsmallmanufacturingcompanies,offeringtrainingandexecutioninOperationalExcellence.Focusingontheanalyticskillsandsystemsapproachofoperationsmanagement,Ombuhelpscompaniesachieveefficient,effectiveprocessandregulatorycompliance.RiskManagement-ISO149713OmbuEnterprises,LLCOutline•StatusofISO14971:2007•Linkstoregulatoryrequirements(QSR&ISO13485)•OverviewofISO14971:2007•Q&Asession•SummaryandConclusions•QuestionsRiskManagement-ISO149714OmbuEnterprises,LLCOurClass•Ourapproachiscasual•Writeyournameonatabletent•Turnoffyourcellphonesduringtheclass•Asklotsofquestions•Bringexamplesfromyourexperience•Participate•Havefun!RiskManagement-ISO149715OmbuEnterprises,LLCParticipantIntroduction•YourName•Yourcompany•Yourjobtitle•SomethingabouttheRiskandHazardAssessmentforMedicalDevicesissuesyoufaceinyourcompany•SomethingaboutRiskandHazardAssessmentforMedicalDevicesthatyouwanttoknowRiskManagement-ISO149716OmbuEnterprises,LLCDanO’Leary’sBiography•Danhasmorethan30yearsexperienceinquality,operations,andprogrammanagementinregulatedindustriesincludingaviation,defense,medicaldevices,andclinicallabs.•DanearnedaMastersDegreeinMathematics•DanisanASQcertifiedBiomedicalAuditor,QualityEngineer,ReliabilityEngineer,andSixSigmaBlackBelt.HeiscertifiedbyAPICSinResourceManagement.RiskManagement-ISO149717OmbuEnterprises,LLCTheCurrentStatusofISO14971:2007RiskManagement-ISO149718OmbuEnterprises,LLCISO14971:2007Development•ISO14971:2007isthesecondedition–Itreplacestheyear2000edition(ISO14971:2000)–Italsoreplacesamendment1tothe2000edition(ISO14971:2000/Amd1:2003)•ThesecondeditionwaspublishedonMarch1,2007•ISO14971ismanagedbyISOTC210–QualitymanagementandcorrespondinggeneralaspectsformedicaldevicesRiskManagement-ISO149719OmbuEnterprises,LLCFDARecognitionStatus•TheFDArecognizedthecurrentversiononSep.12,2007.•Theirrecognitionextendstothewholestandard•Adeclarationofconformitymeansthat–(1)aprocessappropriateformedicaldevicesandtheiraccessories,includinginvitrodiagnosticdevices,hasbeenusedtoidentifyhazardsandhazardoussituations,estimateandevaluatetherisks,controlthoserisksincludingoverallresidualrisk,andmonitortheeffectivenessofthecontrols,and–(2)criteriabaseduponapplicablenationalorregionalregulations,relevantinternationalStandards,informationsuchasthegenerallyacceptedstateoftheart,andknownstakeholderconcernswasusedtodetermineriskacceptability.RiskManagement-ISO1497110OmbuEnterprises,LLCENISO14971Status•ENISO14971:2009–ThecurrentversionisENISO14971:2009Medicaldevices-Applicationofriskmanagementtomedicaldevices(ISO14971:2007,Correctedversion2007-10-01)–ConformitytoENISO14971:2007expiredonMarch21,2010RiskManagement-ISO1497111OmbuEnterprises,LLCENISO14971Versions•ManyENstandardsstartwithanISOversion•Variousstandardsbodiesmayadoptthem,addinformation,andrenumberthem.ISO14971:2007ENISO14971:2007ENISO14971:2009CENdoesn’tsellstandards;purchasethemthroughnationalstandardsbodies.Asaresult,thestandardsarerenumbered(again).I.S.ENISO14971:2009BSIENISO14971:2009DINENISO14971:2009RiskManagement-ISO1497112OmbuEnterprises,LLCLinkstoRegulatoryRequirements(QSR&ISO13485)RiskManagement-ISO1497113OmbuEnterprises,LLCQSRRequirementsforRiskAnalysis•TheFDArequiresriskassessmentaspartofdesignvalidation.(820.30(g))•Designvalidationmeansestablishingbyobjectiveevidencethatdevicespecificationsconformwithuserneedsandintendeduse(s).(820.3(z)(2))•Sincemedicaldevicesneedtobothsafeandeffective,riskmanagement,startinginthedesignphase,isanaturalapproach.RiskManagement-ISO1497114OmbuEnterprises,LLCISO13485:2003&RiskManagement•Clause7.1requires,“...riskmanagementthroughoutproductrealization.”–Inaddition,“Recordsarisingfromriskmanagementshallbemaintained”–ThestandardrecommendsISO14971forguidancerelatedtoriskmanagement.•Clause7.3.2saysthatdesignanddevelopmentinputsincluderiskmanagementoutputs.RiskManagement-ISO1497115OmbuEnterprises,LLCAnOverviewofISO14971:2007RiskManagement-ISO1497116OmbuEnterprises,LLCRiskAnalysisClause4RiskAnalysisClause4RiskEvaluationClause5RiskEvaluationClause5RiskControlClause6RiskControlClause6ResidualRiskEvaluationClause7ResidualRiskEvaluationClause7RiskManagementReportClause8RiskManagementReportClause8TheRiskManagementFlowProduction&Post-productionInformationClause9Production&Post-productionInfor