Practices for Risk Management in Device Manufacturers（Susan Alpert）

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1、PracticesforRiskManagementinDeviceManufacturersPresentationOutlineSusanAlpertPh.D.,M.D.SeniorVicePresidentChiefRegulatoryOfficerMedtronic,Inc.RiskManagementBeginswithDeviceDesignSectionSeparator-Designpracticesandriskevaluation-Riskcontrolapproaches-Pre-marketreviewa

2、ndlabelingasriskmanagement-Risk/benefitassessments2Title

3、DescriptionDeviceEventReportingSupportsContinuedRiskEvaluation-Fieldexperienceasalearningenvironment-Broadpatientpopulationsandexpandeduserenvironments-Eventfeedbackimportancetodesignimprovement3Title

4、Descripti

5、onSystemsareKeytoLearningandUnderstanding-Informationcollectionfromusersandunderstandingofclinicalpractice-Patientcharacteristicassessments-Manufacturer'sfieldpersonnelandhealthcareprofessionalsbothimportant-Eventandneareventcollectionrequiresystemsthatcansupportvolu

6、meandassessment4Title

7、DescriptionManufacturerRoles-Analysisofinformationanddataareongoingatthemanufacturer-Assessmentisinrelationtodesignandearlyriskcontrol-Evaluationrequirementsincludedeepdesignknowledge-Efficientsystemsareriskbased5Title

8、DescriptionEventandDataAss

9、essment-Returnedproductevaluationsbymanufacturer-Trendevaluationsglobalandlocal-Timingofinvestigations-Newtesting-evaluationcontinues6Title

10、DescriptionRegulatorandManufacturerInteractions-Notharmonizedaroundtheworldandcomplicated-Knowledgeandexperiencearedifferentine

11、acharea-Governmentsystems'capacityasafactor-Settingprioritiesandeventimpactassessmentsrequireinteractions-Entitiessharerisk/benefitassessmentandriskcontrolapproaches-Patientimpactforallpotentialactionsisconsidered7Title

12、DescriptionItisabout:-Ongoingrisk/benefitevalua

13、tions-Gettingthebestdataonevents-Understandingrisk,datasourcesanddataimpact-Partnershipsamongallsectors:manufacturers,users,regulators,payers,patients-Decisionsthatareriskbasedandinthebestinterestofallpatients8Title

14、DescriptionThankYou