Medical Device Software Risk Management and Assurance Case 2014

Key Topics

• Risk Management to ISO 14971:2012
  • Risk Management Life Cycle
  • Risk Management Planning
  • Initial (unmitigated) Risk Assessment
  • Hazard Identification
  • Mitigation Architectures
  • Mitigation Strategies and Priorities
  • Residual Risk - Safety Integrity Levels
  • Post Mitigation Risk
  • Safety Requirements
  • European special requirements (Z-Annexes)
  • Verification Planning
  • Hazard Mitigation Traceability
  • Failure Mode and Effect Analysis
  • Architectures, Redundancy and Diversity
• Introduction into Risk Management and Quality System Integration
  • Risk Management Lifecycle and stakeholders
  • Why risk management?
  • How to Implement Risk Management into ISO13485
  • Risk Management Benefits
• Safety / Assurance case
  • Documentation of Basic Safety
  • Safety classes
  • External safety
  • Documentation of essential performance
  • Assurance case vs. Risk Management Report
  • Verification of safety properties
• Software Risk Management (IEC62304 / FDA software reviewers` guidance)
  • Software Hazard Mitigation Strategies
  • Critical Software Issues
  • Software Failures as Hazard Sources
  • Software Item, Unit and System Definition
  • Software Tools and Development Environment
  • Software Requirements and Design Specification
  • Real-Time System Challenges
  • Software Unit and Integration Testing
  • Mitigation Traceability and Effectiveness
  • Software Verification and Validation
  • Software Risk Management Process integration into ISO14971
  • Software Maintenance and Configuration Control
  • FDA documentation requirements
  • Legacy Software issues
  • Upcoming changes in IEC62304:2014

Who should Attend

• Quality Professionals
• Senior Quality Managers
• Compliance Professionals
• Regulatory Professionals
• Design Engineers
• Project Managers
• Process Owners
• Software Engineers
• Quality Auditors
• Quality Engineers
• Legal Professionals
• Medical Affairs