Hi,

It’s very important to do the human factors evaluation. It shows the interactions between the device and the user. It’s performed to make some manipulations to the device and perhaps replace some components. It is crucial when we want to know the interference between the user and medical device. When human factors are considered the device is safer and easier to use. The devices operation is better understood. It also show easier methods of device maintenance and repair. So, even the validation is not required the human factor study should be executed.

Thanks