ISO 14971:

From Risk of Failure Mode to Risk of Harm

Techniques for Linking FMEAs to Risk Assessments

 

A Hands-On Workshop with Dr. Naveen Agarwal

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Join Dr. Agarwal for this provoking and informative seminar.

 
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 Learning Objectives

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.01

Understand ISO 14971:2019 requirements for Risk Analysis, Estimation and Evalutation

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.02

Understand basic terms and how they relate to assessing risks as required by ISO 14971

 
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.03

Understand why an FMEA is only one part of the overall Risk Assessment

 
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.04

Understand basic probability concepts with practical, hands-on examples

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.05

Learn practical techniques to bridge the gap from FMEAs to Risk Assessments

 
 
 

 
 
 

This workshop is perfect for:

  • Design Quality Engineers

  • Product Quality Engineers

  • Quality Managers

  • Risk Managers

  • Product Developers

  • Product Engineers

  • Regulatory Affairs Managers

  • Medical Safety Officers

 

You will receive:

  1. Certificate of completion

  2. Workshop slides

  3. Breakout session slides and worksheet

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