Applying ISO14971 and IEC62304 - A guide to practical Risk Management 2019 is a seminar that covers topics such as:
- 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
Applying ISO14971 and IEC62304 - A guide to practical Risk Management 2019 is intended for:
- Project Managers
- Quality Assurance Managers
- Software Engineers
- Regulatory / Compliance Managers and Specialists
- Hardware Engineers
- System Engineering