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.

This audio conference covers:

• 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

About the speaker:

Markus Weber is the Principal Consultant with System Safety, Inc. and specializes in safety engineering and risk management for critical medical devices. He graduated from Ruhr University in Bochum, Germany with an MS in Electrical Engineering. Before founding System Safety, Inc., he was a software safety engineer for the German approval agency, TUV.

Since 1991, Markus has been a leading consultant to the medical device industry on safety and regulatory compliance issues, specifically for active and software-controlled devices. In conjunction with the FDA, he has published works on risk management issues and software-related risk mitigations. He has helped multiple companies, from startups to Fortune 500 firms, implement successful risk management processes.

Who should attend?

• Project Managers
• Regulatory Affairs
• System Engineers
• R&D
• Compliance Managers
• Regulatory and Compliance Associates

*Please note: Each registration covers one line connected to the audio conference. Attendees dialing from separate locations are required to have separate registrations.