Medical Devices 2011 - The Use and Mis-use of FMEA in Medical Device Risk Management

FMEA is a tool designed for product reliability, which has been modified for use in risk management but has some pitfalls in this use. The presentation will discuss the proper use of FMEA in risk management and how to recognize and avoid the traps associated with this tool in order to have a more efficient risk management process.

Areas Covered in the seminar:
How should I use FMEA in performing risk management?
What are the problems with FMEA in risk management?
How should detectability be used in FMEA?
Is there a role for RPN (Risk Priority Number)?
Are there other tools to use in conjunction with FMEA?
Are there FMEA applications in production as well as design?

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