Link between Risk Management, Usability Engineering and R&D in Medical Devices

[Marcelo]

Hello all

I was making a risk management mini-course and found an image i´ve got from the web a lot of time ago...don´t remember the source, but it´s an interesting pictorial view of the general links between risk management, usability engineering and product design and development in the medical device field.

As the links between these processes are a little difficult to grasp, i think the picture will help.

 

[shala]

Hello
Is it possible not to repeat risk management activity in usability study and just reference to risk management documents which is completed before.

 

[Ronen E]

Hello
Is it possible not to repeat risk management activity in usability study and just reference to risk management documents which is completed before.

Hi,

I don't see why not, as long as the original risk management process covered the usability risks.

Cheers,
Ronen.