Michael Malis
Quite Involved in Discussions
FDA Position: Use Error is the Manufacturer's responsilbility
1. "Use error is still considered a non-conformity, because human factors and ...similar tools should have been considered during the design phase" - K. Trautman
So how do we identify and assess the severity and motigate errors in user-device interaction?
What conclusions, the results of these answers have have on device user interface and labeling?
What would be consider "enough information" when it comes to the use error risk management?
1. "Use error is still considered a non-conformity, because human factors and ...similar tools should have been considered during the design phase" - K. Trautman
So how do we identify and assess the severity and motigate errors in user-device interaction?
What conclusions, the results of these answers have have on device user interface and labeling?
What would be consider "enough information" when it comes to the use error risk management?