A Formal Approach to Pre-Market Review for Medical Device Software

In this paper we explore a method for carrying out pre-market analysis of software designs and implementations, based on formal-methods techniques, to aid the process of reviewing software in medical devices. We discuss a methodology to validate medical device software with the help of formal methods based usage models, and test cases derived from such models. We present a case study involving the design and verification of a generic infusion pump usage model, detailing how the various stages of our approach can be carried out. Finally, we present experimental results and effort estimates to show that the proposed methodology is effective and feasible