Applying ISO14971 and IEC62304 - A guide to practical Risk Management 2013 is a seminar dedicated to compliance issues relating to IEC 62304, ISO 14971 and IEC60601-1:2005 with a focus on the practical means and cross-standard to integrate activities to cover all three requirements documents:
- IEC60601-1:2005 (Technical standards for the safety and effectiveness of medical electrical equipment)
- Section 4 Risk Related Issues
- References to Risk Management
- The IEC TRF (technical report form)
- Compliance for Non-Software Related Issues
- PEMS and IEC62304
- Special PEMS Issues
- ISO 14971 (Requirements for a risk management system for medical devices)
- Risk Management Life Cycle
- Risk Management Planning
- Hazard Domains
- Hazard Identification
- Risk Rating Methods
- Hazard Latency Issues
- Mitigation Strategies and Priorities
- Initial (unmitigated) Risk Assessment
- Alarm Systems as Mitigations
- Mitigation Architectures
- Post Mitigation Risk
- Risk Control Bundles
- Safety Integrity Levels
- Residual Risk
- Safety Requirements
- Usability as Hazard Source and Mitigation
- Verification Planning
- Hazard Mitigation Traceability
- Failure Mode and Effect Analysis / FTA
- Architectures, Redundancy and Diversity
- System Validation / Mitigation Validation
- Verification Strategies
- IEC62304 (International standard for medical device software)
- 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
Applying ISO14971 and IEC62304 - A guide to practical Risk Management 2013 is intended for:
- Regulatory / Compliance Managers and Specialists
- Project Managers
- System Engineering
- Quality Assurance Managers
- Software Engineers
- Hardware Engineers
