Medical device professionals know that risk management is a critical and integral part of Design Control.

Many engineers find the task mundane and boring and could miss some of the great benefits this tool offers. We strive to make our training practical and interesting. 

Our workshop provides a general overview of how Risk Management is integrated into a product's life cycle.  We'll discuss the different phases of risk management and how to properly link and trace risk with system requirements.  

We then look at some analysis tools.  You'll learn the difference between FMEA and FMECA, and the advantages of FTA over FMEA.  The workshop is designed to walk the student through numerous exercises.  Use our procedures for training or let us custom design the course with your procedures.  We have done so for a multi-billion dollar Med Device Firm. 

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What can our validation experts do for your team?

  • Develop an interesting and engaging training session for your staff using your procedures.
  • Provide hands-on Step by Step training on FMEA and FMECA.
  • Recommend best practices on how to calculate and simulate detection and occurrence