Medical Devices Industry and Risk Management 2017
- Start Date:
- Thursday, 27 April, 2017
- End Date:
- Friday, 28 April, 2017 6:00pm
- Pain Management, Emergency Medicine, Physical Medicine, Headache / Migraine, Health & Nutrition
Overview:Gaps, incorrect or incomplete implementation of software can delay or make the certification/approval of medical products impossible. Most activities cannot be retroactively performed since they are closely linked into the development lifecycle. Diligent, complete and correct implementation of risk management from the start of product development is therefore imperative. This course will introduce all necessary steps to design, implement and test critical medical device software in a regulatory compliant environment.
Software risk management has to be embedded into the bigger scope of overall risk management. Therefore this course will additionally address the system level risk management and the resulting interfaces to software.To comprehensively summarize all risk related activities and to demonstrate the safe properties of a device the 'Safety Case' or 'Assurance Case' document is a well-established method to collect all safety related information together in one place.
This documentation will most likely become mandatory for all devices (currently only required for FDA infusion pump submissions). This course will introduce the basic concepts and content of safety assurance cases and will illustrate the usefulness for internal and external review of safety related information.Who will benefit:The course will introduce the main elements of risk management with emphasis on software issues and the application of risk management principles and requirements to the medical device development cycle.
Risk management has become the method of choice to ensure an effective and safety oriented device development. International consensus, reflected in globally applicable standard requirements, has led to risk management being a mandatory component of almost any activity in the medical device industry.The course will emphasize the implementation of risk management into the development and maintenance process. It will use real-life examples and proven tips and tricks to make the application of risk management a practical and beneficial undertaking.
This seminar will address the system level issues of risk management as well as the increasingly important software related issues of critical systems. It will help to comply with regulatory requirements with minimized overhead and resource burden. To make the combines effort to design, implement and verify a safe device transparent the concept of an assurance case will be introduced.The course is mainly based on international consensus requirements such as ISO14971 and IEC62304.Following personnel will benefit from the course:Senior Quality ManagersQuality ProfessionalsRegulatory ProfessionalsCompliance ProfessionalsProject ManagersDesign EngineersSoftware EngineersProcess OwnersQuality EngineersQuality AuditorsMedical AffairsLegal ProfessionalsAgenda:Lecture 1:Introduction into Risk Management and Quality System IntegrationWhy risk management?Historical perspectiveInternational regulatory / statutory requirementsRisk Management Lifecycle and stakeholdersOver-reaching conceptIntegration into ISO13485Lifecycle stepsRisk Management BenefitsLiability issuesStreamlining product developmentImproving product safety and qualityHow to Implement Risk Management into ISO13485SOP frameworkPlanning and executionMonitoring and controlTips and tricksLecture 2:Risk Management to ISO 14971:2012Risk Management PlanningRisk Management Life CycleHazard IdentificationHazard DomainsHazard Latency IssuesRisk Rating MethodsInitial (unmitigated) Risk AssessmentMitigation Strategies and PrioritiesMitigation ArchitecturesAlarm Systems as MitigationsRisk Control BundlesPost Mitigation RiskResidual RiskSafety Integrity LevelsEuropean special requirements (Z-Annexes)Safety RequirementsHazard Mitigation TraceabilityVerification PlanningArchitectures, Redundancy and DiversityFailure Mode and Effect AnalysisTips and TricksQ&ADay 2 ScheduleLecture 1:Software Risk Management (IEC62304 / FDA software reviewers' guidance):Critical Software IssuesSoftware Hazard Mitigation StrategiesSoftware Item, Unit and System DefinitionSoftware Failures as Hazard SourcesSoftware Requirements and Design SpecificationSoftware Tools and Development EnvironmentSoftware Unit and Integration TestingReal-Time System ChallengesSoftware Verification and ValidationMitigation Traceability and EffectivenessSoftware Maintenance and Configuration ControlSoftware Risk Management Process integration into ISO14971Legacy Software issuesFDA documentation requirementsUpcoming changes in IEC62304:2014Tips and TricksQ&ALecture 2:Safety / Assurance caseSafety classesBasic Safety / EnvironmentEssential performanceDocumentation of Basic SafetyElectrical SafetyMechanical SafetyEMC / RFI safetySafety marginsDocumentation of essential performanceWhat is essential performance?Device architectures and mitigation allocationDevice specific mitigationsSoftware mitigationsExternal safetyUser intervention and alarmsOrganizational measuresLevels of protection conceptVerification of safety propertiesType testingSample testingSoftware verification testingInspectionsAnalysesAssurance case vs.
Risk Management ReportGeneral safety and hazard avoidanceDevice / application specific issuesTips and TricksQ&ASpeaker:Markus Weber,Principal Consultant, System Safety Inc. Markus Weber, Principal Consultant with System Safety, Inc., specializes in safety engineering and risk management for critical medical devices. He graduated from Ruhr University in Bochum, Germany with a MS in Electrical Engineering. Before founding System Safety, Inc., he was a software safety engineer for the German approval agency, TUV.
Since 1991, Mr. Weber has been a leading consultant to the medical device industry on safety and regulatory compliance issues, specifically for active and software-controlled devices. In conjunction with the FDA, he has published works on risk management issues and software-related risk mitigations. Mr. Weber has helped multiple companies, from startups to Fortune 500 firms. Location: Seattle, WADate: April 27th & 28th, 2017 and Time: 9:00 AM to 6:00 PM Venue: Courtyard Seattle Sea-Tac AreaAddress: 16038 West Valley Highway Tukwila Washington 98188 USA Phone: (425) 255-0300 Price: Register now and save $200. (Early Bird) Price: $1,295.00 (Seminar Fee for One Delegate) Until March 20, Early Bird Price: $1,295.00 From March 21 to April 25, Regular Price: $1,495.00 Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)* Quick Contact:NetZealous DBA as GlobalCompliancePanel Phone: 1-800-447-9407Fax: 302-288-6884Email: email@example.com Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel?Like us our Facebook page: https://www.facebook.com/TrainingsAtGlobalCompliancePanel/Follow us on Twitter: https://twitter.com/GCPanel
Hotel: Courtyard Seattle Sea-Tac Area 16038 West Valley Highway Tukwila Washington 98188 USA Phone: (425) 255-0300
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