Demonstrating that medical devices satisfy user related safety requirements

Harrison M, Masci P, Campos JC, Curzon P.  2017.  Demonstrating that medical devices satisfy user related safety requirements. Software Engineering in Healthcare (FHIES/SEHC 2014). 9062 copy at

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Lecture Notes in Computer Science

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One way of contributing to a demonstration that a medical device is acceptably safe is to show that the device satisfies a set of requirements known to mitigate hazards. This paper describes experience using formal techniques to model an IV infusion device and to prove that the modelled device captures a set of requirements. The requirements chosen for the study are based on a draft proposal developed by the US Food and Drug Administration (FDA). A major contributor to device related errors are (user) interaction errors. For this reason the chosen models and requirements focus on user interface related issues.

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