30th Annual International Computer Software and Applications Conference (COMPSAC'06) A Formal Approach to Pre-Market Review for Medical Device Software Chicago, Illinois September 17-September 21 ISBN: 0-7695-2655-1
Formal methods have long been proposed as an effective technique for developing safety-critical software. However, few medical device manufacturers employ such methods. One way to encourage the use of formal methods is to leverage these techniques in such a way as to enhance the review process for regulatory bodies, such as the U.S. Food and Drug Administration. 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.
Citation:
Raoul Jetley, S. Purushothaman Iyer, Paul L. Jones, William Spees, "A Formal Approach to Pre-Market Review for Medical Device Software," compsac, vol. 1, pp.169-177, 30th Annual International Computer Software and Applications Conference (COMPSAC'06), 2006 Usage of this product signifies your acceptance of the Terms of Use. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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