By analyzing the full scope of all possible results of a particular situation, an efficient risk analysis can identify not only the main difficulties, but also good new opportunities. In other words, the risk analysis can be carried out both qualitatively and quantitatively. In a qualitative risk analysis, a situation is usually judged instinctively or "out of instinct" and then characterized with utterances such as "that seems too risky" or "it will probably be profitable". In the case of a quantitative risk analysis, on the other hand, attempts are made to assign figures to the risk, either by using empirical data or by determining qualitative evaluations. We focus on quantitative risk analysis.
The risk analysis is a part of the risk management process according to ISO 14971. During the risk analysis, the hazards of the medical device are to be identified. The risk is classified by estimating the probability of occurrence of a risk in conjunction with the degree of severity. In addition, a decision is made on the acceptability of a risk and measures are defined which are intended to contribute to risk minimization.