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Applying ISO14971 and IEC62304 - A guide to practical Risk Management 2017

Start Date:
Thursday, 9 March, 2017
End Date:
Friday, 10 March, 2017 6:00pm
Hepatology, Infectious Disease, Rheumatology, Internal Medicine, Emergency Medicine, Pulmonary Medicine, Physical Medicine, Sports Medicine

Overview: Gaps, incorrect or incomplete implementation of safety functionality 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 devices in a regulatory compliant environment.

This course will additionally address the software risk management and the resulting interfaces to device level risk management.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 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 and usability 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, IEC62366 and IEC62304.

It will cover European (MDD), US (FDA) and international risk management requirements from a regulatory and practitioner's perspective.Following personnel will benefit from the course:Senior quality managersQuality professionalsRegulatory professionalsCompliance professionalsProject managersDesign engineersSoftware engineersProcess ownersQuality engineersQuality auditorsMedical affairsLegal ProfessionalsAgenda:Day 1 Schedule: 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 controlLecture 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 Schedule: Lecture 1:Usability and Risk ManagementUse errors as hazard sourceUser intervention as hazard mitigationUsability engineering lifecycleApplication specificationUsability SpecificationFrequently used functions / primary operating functionsUsability verification / validationUpcoming changes IEC62366:2014Lecture 2: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 EnvironmentLecture 3:Software Risk Management (IEC62304 / FDA software reviewers' guidance):Software 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 TricksLecture 4: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 WeberPrincipal 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: San Diego, CA Date: March 9th & 10th, 2017 and Time: 9:00 AM to 6:00 PM Venue: Four Points by Sheraton San Diego DowntownAddress: 1617 1st Avenue - San Diego, California, 92101 - United States Price: Register now and save $200. (Early Bird) Price: $1,295.00 (Seminar Fee for One Delegate) Until January 31, Early Bird Price: $1,295.00 from February 01 to March 07, 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:


Four Points By Sheraton San Diego Downtown 1617 1st Avenue - San Diego,
92101 - United States

Organizer Details

Conference organized by NetZealous DBA as GlobalCompliancePanel

NetZealous LLC-globalcompliancepanel, 161 Mission Falls Lane, Suite 216, Fremont,CA94539, USA
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