Hazard analysis - a practical guide
Overview: 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
Why hazard analysis matters
What is required under IEC60601 and ISO14971
Obtaining buy-in from team members
How to conduct hazard analysis more efficiently
Maximising benefit from hazard analysis
Effective evaluation strategies and documentation formats
Who will benefit:
Project managers
Regulatory affairs
System engineers
R&D
Compliance managers
Regulatory and compliance associates
Markus Weber, Principal Consultant with System Safety, Inc., specialises in safety engineering and risk management for critical medical devices. He graduated from Ruhr University in Bochum, Germany with a MS in Electrical Engineering. Before founding System Safety, Inc., he was a software safety engineer for the German approval agency, TUV. Since 1991, Mr. Weber 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. Mr. Weber has helped multiple companies, from startups to Fortune 500 firms.
Date: 18 September 2012Time: 10:00 - 11:00
Venue: Online Training, Wilmington
Cost: $245.00
More info:
Online Training