A Colored Petri Nets model of the risk management process based on the ISO 14971 standard

Medical devices help physicians to diagnose and treat patients at home and healthcare facilities. However, when complexity of devices grows, new risks can also arise and put users in hazard situations. Manufacturers must develop medical devices taking into account ways to mitigate risks and avoid injuries to users. In this context, regulatory agencies impose the ISO 14971 standard during the risk management of medical devices. The ISO 14971 specifies risk management process activities and suggests manufacturers to use techniques such as the Failure Mode Effects and Criticality Analysis (FMECA). Nevertheless, the ISO 14971 is a subjective document written in natural language. Therefore, the correct interpretation of its requirements depends on the understanding of manufacturers. This paper presents a Colored Petri Nets (CPN) model of the risk management process based on the ISO 14971 and FMECA technique. The model aims to deal with the subjectivity problem of the ISO 14971. Besides, we verified and validated abstract and detailed versions of the model using model checking and simulation results to increase confidence on the specification.