If you have participated in hazard analysis meetings, you have probably spent hours discussing whether a scenario is a hazard, or the cause of a hazard, or debating whether the probability of an unmitigated hazard is high or low, or went off on a tangent evaluating very unlikely hazard scenarios, or wrestled with group members who consider hazard analysis meetings a waste of time.
This presentation looks at what is required under IEC60601 and ISO14971, and provides guidance on how to motivate groups to perform hazard analyses, structure meetings effectively and make them meaningful. It discusses documentation formats and hazard evaluation strategies, as well as presenting ideas on how to get the most benefit out of the risk management process.
Areas Covered in the Session
Who Will Benefit:
- Why hazard analysis matters
- What is required under IEC60601 and ISO14971
- Obtaining buy-in from team members
- How to conduct hazard analysis more efficiently
- Maximizing benefit from hazard analysis
- Effective evaluation strategies and documentation formats
- Project Managers
- Regulatory Affairs
- System Engineers
- Compliance Managers
- Regulatory and Compliance Associates