Medical Device Software Risk Management and Assurance Case 2014 is a seminar that covers topics such as:
- 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
Medical Device Software Risk Management and Assurance Case 2014 brings together:
- 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