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Boston Conference on FDA Device Software Regulation

You need to understand and apply the current provisions that NIST has put forth in recent reports FDA will integrate them into its regulatory oversight.

Day 1 Schedule: Lecture 1:FDA authority and regulatory programTypes of Software are devicesRegulatory strategyRisk classificationFunction and outcomeMedical Device Data Systems (MDDS)Office of the National Coordinator (ONC) for Health Information ProtectionSoftware regulatory applicationsFDA GuidancePremarket submissionsParadigms: aeronauticsQuality System Regulation (QSR)Design verification and validationVoluntary standardsCorrective and Prevent Action PlansVoluntary standardsRecalls:Service / maintenance / recall.Implementation strategyCorrections and Removals reportingUpdates: FDA vs. non-FDAPredictive analyticsLecture 2:InteroperabilityCompatibility by designHardwareSoftwareLabelingPrecautionsInstructions for useUse of Voluntary StandardsProprietary informationFailure management / follow upUser's vs. manufacturer's legal responsibilitySystem configurationCustomizationEnvironment of useProfessionalHome useDay 2 Schedule: Lecture 1:CybersecurityDevice vulnerabilities: malfunction and failurePre-emption designLatent malware/virusPost-event managementCorrective action for softwareDisclosure to usersNational Institute of Science and Technology ReportLecture 2:Medical Mobile Applications (mobile apps)Mobile apps defined as a deviceFDA regulatory strategyFDA guidanceNational Institute of Science and Technology Report and CollaborationUpdates (FDA vs. non-FDA updates)Criteria for corrective and preventive action deemed recallsReports of Corrections and RemovalsReports of adverse eventsProfessional vs. lay use / home useLabeling: instructions for use and precautionsEnvironment of useFDA regulation of accessoriesFederal Communications Commission (FCC) regulation


21 Apr 2016 @ 09:00 am

22 Apr 2016 @ 06:00 pm

Duration: 1 days, 9 hours


Courtyard Boston Logan Airport

225 William F McClellan Hwy

United States



Organised by

GlobalCompliancePanel (deactivated)

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