Webinar:AgileDesignControlsPart2
DynamicRiskManagementforSoftware-IntensiveMedicalDevices
March2019
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ArnaudAlberts WolfgangHuber AaronJosephMatrixRequirementsGmbH MatrixRequirementsGmbH Sunstone Pilot,Inc.
AaronJosephPrincipalConsultant– SunstonePilot,Inc.• 20+yearsmedicaldevicedevelopmentoverawiderangeofproducts:
• surgicalroboticssystems,digitalx-rayfluoroscopysystem,druginhalerdevices,roboticcathetersystem,x-raycatheterforbrachytherapy,lasereyesurgerysystem,heart-lungbypassmachine,andmultiplewearable/IOTdevices
• Assistclientswithallaspectsofdesigncontrols:riskmanagement,requirementsmanagement,V&Vtesting,refiningdesigncontrolsprocedures,andtrainingR&Dstaff• Avidpromoterofleanandagilemethodsformedicaldevicedevelopment• BSEE- RiceUniversityandMSBioengineering- UniversityofWashington• BasedinSiliconValley
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ArnaudAlbertsGrowthManager– MatrixRequirementsGmbH
• Helpingmedicaldevicecompaniestobuildtheirdeviceinanagilewayfacilitatingthemanagement,thedocumentationandthecertificationoftheirproductwithMatrixRequirementsapplications.• QAengineerandProductManagementinaStartupMedicalDevicecompany
• Hardware +softwareclass2MedicalDevice• BuildingtheQAsystemformarketintroduction• Validation,Riskassessmentandtesting• Productenhancement,releases,documentation
• M.Sc.Bio-Engineering– ULBBrussels• BasedinBrussels- Belgium
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WolfgangHuberCo-Founder- MatrixRequirementsGmbH• FounderMatrixRequirements• 15+yearsmanagingmedicaldevicedevelopment• 10+yearsdevelopingversioncontrolanddocumentmanagementsystems• 30yearsexperienceprofessionalsoftwaredevelopment• Earlyadaptorofagilemethodologies• M.Sc.ComputerScience– KarlsruheUniversity• BasedinMunich,Germany||Beziers,France
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WebinarOutline1. Requirementsmanagement2. Basicmodelforriskanalysisandriskcontrols3. Examplechangescenario4. ImplementingchangeswithJiraandMatrix5. Toolconfigurationsforefficientriskandrequirementsmgmt6. Q&A
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ExampleConnectedMedicalDevice
Firmwareonwatch
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• Wearabledevice+mobileapp+cloud• Heartmonitor(includinganalysisofotherpatientdata)• Distributedarchitecturewithmultiplesoftwareplatforms
Mobileapponsmartphone
Dataanalysisandstorageoncloudplatform
Browserorclientapponlaptop
ExampleConnectedMedicalDevice
Firmwareonwatch
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Mobileapponsmartphone
Dataanalysisandstorageoncloudplatform
Browserorclientapponlaptop
Change:lateindevelopment,theteamdiscoversaproblemduringusabilitytestingà necessitateschangestoGUIonwatchandsmartphoneandretesting
DHFdocuments
ExampleofMatrixscreenshots:riskcreation
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OrwecanfocusonRISKwithoutmitigationfirst
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Themitigation
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traceability
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Doc(shortvideobettertogothroughthem)
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Excelexport
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ArnaudAlbertsWolfgangHuberMatrixRequirementsGmbH- matrixreq.com
AaronJosephSunstonePilot,Inc.- sunstonepilot.com
Q&A