%0 Conference Paper %B Software Engineering in Healthcare (FHIES/SEHC 2014) %D 2017 %T Demonstrating that medical devices satisfy user related safety requirements %A Michael Harrison %A Paolo Masci %A José Creissac Campos %A Paul Curzon %C Washington, DC, USA %I Springer %S Lecture Notes in Computer Science %V 9062 %X

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.

%8 July %> https://haslab.uminho.pt/sites/default/files/jccampos/files/harrison-fhies14.pdf