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As software becomes ever more ubiquitous and complex in medical devices, it becomes increasingly important to assure that it performs safely and effectively. The critical nature of medical devices necessitates that the software used therein be reliable and free of errors. It becomes imperative, therefore, to have a conformance review process in place to ascertain the correctness of the software and to ensure that it meets all requirements and standards. Formal methods have long been suggested as a means to design and develop medical device software. However, most manufacturers shy from using these techniques, citing them as too complex and time consuming. As a result, (potentially life-threatening) errors are often not discovered until a device is already on the market. In this paper we present a reference model based approach to software conformance checking. Reference models enable the application of formal methods to software conformance checking, and provide a framework for rigorous testing. To illustrate the approach, we develop the reference model for a generic patient controlled analgesic infusion pump, and explain how it can be used to aid software conformance checking in a regulatory environment.
Date of Conference: 25-27 June 2007