José C. Campos

Citation:

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 www.tinyurl.com/y65s782h

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Abstract:

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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