Rigorous model-based development of programmable electronic medical systems (PEMS): From requirements to code

• Silvia Bonfanti

Many people get in contact with medical devices during their life, e.g. infusion pump, diagnostic X-ray equipment, hemodialysis machine. These devices were based on mechanical and electrical components, and all the hardware parts were tested to guarantee their correct functioning. Over the years, the software has increasingly become a critical component of the devices and this has given rise to a new subgroup of medical devices: Programmable Electronic Medical Systems (PEMS). PEMS are safety–critical system [78]. They are a combination of hardware and software to implement all the functionalities that have effects on people health and, in case of malfunctions, they can seriously compromise human safety. For this reason, the software installed on these devices must be guaranteed through rigorous processes to assure medical software safety and reliability. Correct operation of a medical device depends upon the software, whose development should adhere to certification standards or guidelines.