Overview: The terms "Hazard and Risk Analysis" and "Failure Mode, Effects and Criticality Analysis (FMECA)" are often used synonymously. However, there are significant differences in both methodologies and their strengths can be combined to ensure a safe and efficacious system design.
The presentation will explain both methodologies and will show ways how these tools can be used to complement each other. Additionally the differences and limitations of both methods will be illustrated and the appropriateness during the different product development phases will be discussed.
Areas Covered in the Session: Hazard analysis techniques FMECA techniques Probabilistic approaches When to use which method during the design process 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.
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