Abstract
Medical devices are safety-critical systems since their malfunctions can seriously compromise human safety. Correct operation of a medical device depends upon the controlling software, whose development should adhere to certification standards.
However, these standards provide general descriptions of common software engineering activities without any indication regarding particular methods and techniques to assure safety and reliability. This paper discusses how to integrate the use of a formal approach into the current normative for the medical software development.
The rigorous process is based on the Abstract State Machine (ASM) formal method, its refinement principle, and model analysis approaches the method supports. The hemodialysis machine case study is used to show how the ASM-based design process covers most of the engineering activities required by the related standards, and provides rigorous approaches for medical software validation and verification.