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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.

Day 1 Schedule Lecture 1: Introduction into Risk Management and Quality System Integration Why risk management? Historical perspective International regulatory / statutory requirements Risk Management Lifecycle and stakeholders Over-reaching concept Integration into ISO13485 Lifecycle steps Risk Management Benefits Liability issues Streamlining product development Improving product safety and quality How to Implement Risk Management into ISO13485 SOP framework Planning and execution Monitoring and control Tips and tricks Lecture 2: Risk Management to ISO 14971:2012 Risk Management Planning Risk Management Life Cycle Hazard Identification Hazard Domains Hazard Latency Issues Risk Rating Methods Initial (unmitigated) Risk Assessment Mitigation Strategies and Priorities Mitigation Architectures Alarm Systems as Mitigations Risk Control Bundles Post Mitigation Risk Residual Risk Safety Integrity Levels European special requirements (Z-Annexes) Safety Requirements Hazard Mitigation Traceability Verification Planning Architectures, Redundancy and Diversity Failure Mode and Effect Analysis Tips and Tricks Q&A Day 2 Schedule Lecture 1: Software Risk Management (IEC62304 / FDA software reviewers' guidance): Critical Software Issues Software Hazard Mitigation Strategies Software Item, Unit and System Definition Software Failures as Hazard Sources Software Requirements and Design Specification Software Tools and Development Environment Software Unit and Integration Testing Real-Time System Challenges Software Verification and Validation Mitigation Traceability and Effectiveness Software Maintenance and Configuration Control Software Risk Management Process integration into ISO14971 Legacy Software issues FDA documentation requirements Upcoming changes in IEC62304:2014 Tips and Tricks Q&A Lecture 2: Safety / Assurance case Safety classes Basic Safety / Environment Essential performance Documentation of Basic Safety Electrical Safety Mechanical Safety EMC / RFI safety Safety margins Documentation of essential performance What is essential performance? Device architectures and mitigation allocation Device specific mitigations Software mitigations External safety User intervention and alarms Organizational measures Levels of protection concept Verification of safety properties Type testing Sample testing Software verification testing Inspections Analyses Assurance case vs. Risk Management Report General safety and hazard avoidance Device / application specific issues Tips and Tricks Q&A

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