Hazard Analysis vs. FMECA – Differences and Commonalities

Live Webinar on

Hazard Analysis vs. FMECA - Differences and Commonalities
Date & Time:


Wednesday, October 26, 2011
10:00 AM PDT | 01:00 PM EDT

Register Now

Duration: 60 Minutes
Instructor: Markus Weber
Location: Online
Price : $245.00 (for one participant)

Instructor Profile:
Overview:
Markus Weber
The terms "Hazard and Risk Analysis" and "Failure Mode, Effects and
Principal Consultant, System
Criticality Analysis (FMECA)" are often used synonymously.
Safety Inc.

However, there are significant differences in both methodologies and
Markus Weber, Principal
their strengths can be combined to ensure a safe and efficacious
Consultant with System Safety, Inc.,
system design. The presentation will explain both methodologies and
specializes in safety engineering and
will show ways how these tools can be used to complement each
risk management for critical medical
devices. He graduated from Ruhr
other. Additionally the differences and limitations of both methods will
University in Bochum, Germany with
be illustrated and the appropriateness during the different product
a MS in Electrical Engineering.
development phases will be discussed.
Before founding System Safety, Inc.,

he was a software safety engineer
Areas Covered in the Session:
for the German approval agency,
TUV. Since 1991, Mr. Weber has
been a leading consultant to the
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Hazard analysis techniques
medical device industry on safety
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FMECA techniques
and regulatory compliance issues,
specifically for active and software-
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Probabilistic approaches
controlled devices....more
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When to use which method during the design process
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Effective evaluation strategies and documentation formats
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Project Managers
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Regulatory Affairs
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System Engineers
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R&D
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Compliance Managers
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RegulatoryandComplianceAssociates
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For more information, please contact the event coordinator. We look forward to seeing you at the webinar.

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Event-coordinator
GlobalCompliancePanel
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