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Software as a Medical Device

SaMD or Software as a Medical Device can be described as a software constructed to be used in medical devices. These softwares can be run on different operating systems and virtual platforms.<br>1.tThe basic programming model of a SaMD is given below.<br>2.tDifferent softwares are used for medical purposes, and they include the following:<br><br>To continue Reading : https://bit.ly/31ItRVc<br>Contact Us:<br>Website : https://bit.ly/2BvO06b<br>Email us: sales.cro@pepgra.com<br>Whatsapp: 91 9884350006<br>

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Software as a Medical Device

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  1. CHALLENGESAND OPPORTUNITIESIN SOFTWAREDRIVEN MEDICALSCIENCES AnAcademicpresentationby Dr.NancyAgens,Head,TechnicalOperations,PepgraGroup:www.pepgra.com Email:sales.cro@pepgra.com

  2. Today'sDiscussion OUTLINEOFTOPICS Introduction ChallengesofMedicalDevice Software DifferentSoftwaresusedforMedical Purposes PremarketNotification InternationalMedicalDeviceRegulator’sForum OpportunitiesAssociatedwithSoftwareDrivenMedicalSciences

  3. Introduction SaMDorSoftwareasaMedicalDevicecanbedescribedasasoftwareconstructedtobeusedinmedicaldevices. ExamplesofSaMDinclude: Standalonesoftwaresrunningongeneralcomputers,smartphonesandtablets.SaMDthatcandetectinterruptedbreathingduringsleepbyusingamicrophoneofasmartdevice. SaMDthatcananalyzetheheartbeatrate. AsoftwarecanbehaveasSaMDwhenitisrunonamedicalhardwaredevice,butdoesnotserveanyintendedpurposeforthehardware.

  4. ChallengesofMedicalDeviceSoftware Softwares,whenusedasmedicaldeviceshaveseveralchallenges,themajoronesbeingclinicalevaluation,scientificvalidityandclinicalvalidation. ClinicalevaluationofSaMDisdescribedasasetofongoingactivitieswhichareconductedtoassessandanalyzetheSaMD'ssafety,performanceandeffectiveness. Scientificvalidity/ValidClinicalAssociationofSaMDreferstotheextentofclinicalacceptanceoftheSaMD'soutputintermsofconcept,conclusionandmeasurements. Clinicalvalidationcanbedescribedastherelationshipbetweenverificationandvalidationresultsofthealgorithmusedandtheclincialconditioninquestion. Contd..

  5. Figure1:SaMDBasic ProgrammingModel

  6. DifferentSoftwaresusedforMedicalPurposes1.ADVANCEDANALYTICS Describedasadevicewhichcanusebigandlargecomplexdatasetsfromavariety ofsourcesbyidentifyingandanalyzingthedata,andusesthisdataformedicaldevices.2.ARTIFICIALINTELLIGENCE ArtificialIntelligencedescribedasadevicewhichmimicshumanlearningandreasoning.3.CLOUD Describedasadevicewhichhasaninternetbasedcomputingsystem,whcihprovideswithcomputerprocessingresourcesanddata. Contd..

  7. Severalresourcessuchasservers,computernetworksandstoragedevicescansharethepoolofdatafromthecloudsystem.Severalresourcessuchasservers,computernetworksandstoragedevicescansharethepoolofdatafromthecloudsystem. 4.CYBERSECURITY Describedasadevicewhichpreventsunauthorizedaccess,misuse,modification,ordenialofuseofanyinformationthatcanbetransferredtoanexternalrecipientfromamedicaldevice. 5.INTEROPERABILITY Adevicethatexchangesandusesinformationwithanothermedical/non-medicalproductviaanelectronicinterface. 6.MEDICALDEVICEDATASYSTEM(MDDS) Asoftwareusedtotransferandstoredata,convertformatsofdataanddisplaydataofthemedicaldevicewithouttheconnectionofanyothermedicaldevice.

  8. PremarketNotification Premarketnotificationisakeyelementfortheregulationofmedicaldevices. Todefinesafetyandeffectivenessofalltypesofmedicaldevices,thefactorstakenintoconsiderationare: Patientpopulationinquestion Labellingandadvertisingofthewaystouseamedicaldevise BalancebetweenbenefitsandriskstohealthwhenusingamedicaldeviceReliabilityofthemedicaldevice

  9. InternationalMedicalDeviceRegulator’sForum TheInternationalMedicalDeviceRegulator’sForum(IMDRF)seekstodemonstratesafety,effectivenessandperformanceofSaMD. Itsuggeststhatasoftwareusedinmedicalsciencesisuniquewithrespecttoitsconnectivity. Themanufacturersofsoftwaresrelatedtomedicaldevicesareencouragedtousethisfeatureofuniquenesstomodifythesoftwarestosuitthereal-worldperformances. Itisimportanttoensuresafetyinthenewtechnologiesusedformedicaldevices,andthewayitisdoneisillustratedbelow: Contd..

  10. Figure2:GoodQuality SystemsEnsureSafety ofPatients

  11. OpportunitiesAssociatedwithSoftware DrivenMedicalSciences Techniquesofadvancedanalyticscanbeusedtoanalyzedatasetswhichnormallycannotbeanalyzedbyhumans. Advancedanalyticscandiscovernewpatternsindata. AIusedinasmartECGdevicecanestimatetheprobableoccurrenceofacutecardiacischemia(ACI) Cardiovascularimagesacquiredfrommagneticresonancescannerscanbeanalyzedbyasoftwarethroughacloud-basedpicturearchivingandcommunicationsystem. Dataofpatientsfromapulseoximetercanbeusedbyadesignedinfusionpumptochangethesettingsofanotherinfusionpumpasperrequirement. Contd..

  12. Figure3a:ScienceCycle Contd..

  13. Figure3b: RegulatoryCycle

  14. ContactUs UNITEDKINGDOM +44-7424810299 INDIA +91-9884350006 EMAIL sales.cro@pepgra.com

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