Re: FMEA Evaluation of "User Risk" - Wording FMEA 3rd party advisors
I´m not sure i understand what you say, there´s too much 3 parties involved :-)
"User risks", and i understand you are talking usability here, can only me mitigated if you talk to users.
The "inventor" of the medical device surely will know hoe he envisions the device to function, but cannot know how the users will behave related to the device if there´s no user interaction in the device development.
I'm a moderator on the medical device forums, so if you need help with something, feel free to ask!