Hazard Analysis vs. FMECA – Differences and Commonalities

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Live Webinar

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Hazard Analysis vs. FMECA – Differences and Commonalities

Date & Time: Wednesday, October 26, 2011

10:00 AM PDT | 01:00 PM EDT

Duration: 60 Minutes

Instructor: Markus Weber

Location: Online

Price : $245.00

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(for one participant)

Instructor Profile:

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: l l l l l

Hazard analysis techniques FMECA techniques Probabilistic approaches When to use which method during the design process Effective evaluation strategies and documentation formats

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Markus Weber Principal Consultant, System Safety Inc. Markus Weber, Principal Consultant with System Safety, Inc., specializes 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 softwarecontrolled devices....more

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