Hello,

The term ‘As Far As Possible’ certainly could pose a difficult situation. However, I believe that there should be no possible risk left unconsidered, even if it is extremely unlikely. The intentions of a medical device is to be safe and effective. With safety being of utmost importance. This is a responsibility that falls on the risk analysis team that would have to do all the appropriate research to ensure that all possible risks have been accounted for. This is an extremely important step in the development of a medical device and requires an experienced team’s effort.

-Romany