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