Wondering aloud: would it make sense to factor in an estimated volume of sales and/or number of users and/or number of procedures when considering harm probabilities?
We've never done this (and I'm curious if anyone does), but does seems reasonable in some way.
That is, the probability occurrence of a harmful event is proportional to the device's use.
All else being equal, a device that is used by millions presumably has a much higher probability of issues that a device that only has a few hundred users.
Curious what others think...
We've never done this (and I'm curious if anyone does), but does seems reasonable in some way.
That is, the probability occurrence of a harmful event is proportional to the device's use.
All else being equal, a device that is used by millions presumably has a much higher probability of issues that a device that only has a few hundred users.
Curious what others think...