FMEA Evaluation of "User Risk" - Wording FMEA 3rd party advisors

[jtavares]

I am in need of a bit of help on how one would word in a FMEA evaluation of "user risk" by using a third party and then mitigation of it by using a third party and the 3rd party is also the inventor. So he is qualified to advise us on how to use the product and the risks and mitigating those risks but he is external and NOT ISO certified.

[Marcelo Antunes]

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.

[Bev D]

yes please clarify your question, it is bit cryptic

[Martin IT]

The first step to mitigate the users' risk is to know how they use the medical
device.
Try to use the report done by the product specialists of your company, they usually are the ones that have an overview of the users. Another way could be the analisys of the service reports, often they are plenty of uncorrect using and behind an uncorrect using there is a possible hazard.