Risk Analysis using Monte Carlo Simulation instead of Scoring and Heat Map


Starting to get Involved
The other day I came across an article that mentioned how the financial industry managed risk using Monte Carlo simulations and the experts in that industry had a disdain for risk assessment done by typical scoring 1-10 likelihood, occurrence and severity method. The argument was that the latter does not have any evidence of being effective, rather it gives a false sense of confidence that risk is being managed appropriately.

I was wondering if anyone in Medical device Industry has ever employed Monte Carlo Simulations for Device Risk Assessment in replacement of Scoring method, or perhaps employed both in some combination.

I have no idea how MCS need to be customized to cater our needs but I love to see an example of this if anyone's made an attempt at it.

Ed Panek

QA RA Small Med Dev Company
Super Moderator
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