one factor to consider is the assessment of the risks of the device. With this assessment you can determine the severity and number of harmful events associated with this device. Also, the probability of harmful events, duration, and the risk from false-positive or false-negative results for diagnostics. The reason why this factor is important is because during analysis, it can help determine whether the device risks are severe or moderate. IT can also help determine whether the device should even be available to people based on its risks. It’s best to figure these things out ahead of time before it causes real harm, and by making this assessment it can help you determine if this device is acceptable or not.