K

#### Kleibeuker

We have an unaceptable risk (before mitigation) and is in the software

(eg due to a bug/stall/whatever)

From IEC:62304 we conclude that we need to develop according Class C.

During the the initial risk assessment the probability was set to 100% because for software we cannot judge the probability properly

Asume no other hardware Risk Controls are possible.

The question is if we can apply some risk reduction for our residual risk

based on the following Risk Control: IEC:62304-Class C

Basically we have to alliviate the probability from 100% to let ssay 10 or 1%

What is the best approach here and what is the amount of risk reduction?