Integrating formal methods into medical software development: The ASM approach

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 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.