nklsoe t1_ix3e6vq wrote
Reply to comment by EzekielNOR in I am a Game Designer / Project lead who spent the last 2 years building brain trauma rehabilitation software for Norway's largest specialist hospital. AMA :> by EzekielNOR
isnt a software like this a class III medical device? are you planning on doing the full conformity assessment process if it qualifies as such?
EzekielNOR OP t1_ix3emre wrote
It isn’t much different from software like Beat Saber and similar when it comes to requirements. However, we’ve gone through conformity assessments in a ROS analysis to make sure patient data is sufficiently protected.
If the software was to be developed further it would be sensible to start extended clinical trials.
Viewing a single comment thread. View all comments