Table 5 Example of risk matrices. Risk matrix based on the semi-quantitative / qualitative classification as given in Table 4. The risk matrix collects all particular risks of a medical device ( R1−R6 in this case) according to its categorization with respect to their probability and severity (basic scheme as presented in [9]). The tree different areas (red/orange – inacceptable risks, green – acceptable risks, and yellow – region where risks need further investigation) indicate which further risk management steps have to be considered before the medical device can be placed on the market
From: Risk-based evaluation of machine learning-based classification methods used for medical devices
