A systematic literature review of the use of formal methods in medical software systems

The use of formal methods is often recommended to guarantee the provision of necessary ser-vices and to assess the correctness of critical properties, such as functional safety, cybersecurity,and reliability, in medical and health care devices. In the past, several formal and rigorous methodshave been proposed and consequently applied for trustworthy development of medical softwareand systems. In this paper, we perform a systematic literature review on the available state of theart in this domain. We collect the relevant literature on the use of formal methods for modeling,design, development, verification,andvalidationof software-intensivemedical systems. We applystandard systematic literature review techniques and run several queries in well-known reposito-ries to obtain information that can be useful for people who are either already working in this fieldor planning to start. Our study covers both quantitative and qualitative aspects of the subject.