Many medical device companies separate System FMEA (scope: the device system) and Application (or Human Factors) FMEA (scope: interfaces between device system and humans). As I have said above, you can do these separately, or combine them into one more comprehensive System FMEA. The key is to show clearly the scope of your FMEA, and to include all of the subsystem-to-subsystem interfaces, as well as the interfaces between users/patients and the device system.
