Applying ISO14971 and IEC62304 - A guide to practical Risk Management 2019

Key Topics

• IEC62304 (International standard for medical device software)
  • Software Verification and Validation
  • Critical Software Issues
  • Software Hazard Mitigation Strategies
  • Software Item, Unit and System Definition
  • Software Tools and Development Environment
  • Real-Time System Challenges
  • Software Requirements and Design Specification
  • Software Failures as Hazard Sources
  • Mitigation Traceability and Effectiveness
  • Software Unit and Integration Testing
• IEC60601-1:2005 (Technical standards for the safety and effectiveness of medical electrical equipment)
  • Section 4 Risk Related Issues
  • References to Risk Management
  • Special PEMS Issues
  • The IEC TRF (technical report form)
  • Compliance for Non-Software Related Issues
  • PEMS and IEC62304
• ISO 14971 (Requirements for a risk management system for medical devices)
  • Verification Strategies
  • Post Mitigation Risk
  • Architectures, Redundancy and Diversity
  • Hazard Mitigation Traceability
  • Residual Risk
  • Failure Mode and Effect Analysis / FTA
  • Alarm Systems as Mitigations
  • Usability as Hazard Source and Mitigation
  • Risk Management Life Cycle
  • Safety Integrity Levels
  • Initial (unmitigated) Risk Assessment
  • Hazard Latency Issues
  • Mitigation Strategies and Priorities
  • System Validation / Mitigation Validation
  • Safety Requirements
  • Mitigation Architectures
  • Risk Rating Methods
  • Hazard Identification
  • Risk Management Planning
  • Hazard Domains
  • Verification Planning
  • Risk Control Bundles

Who should Attend

• Project Managers
• Quality Assurance Managers
• Software Engineers
• Regulatory / Compliance Managers and Specialists
• Hardware Engineers
• System Engineering