@conference {HarrisonMCC:2014, title = {Demonstrating that medical devices satisfy user related safety requirements}, booktitle = {Software Engineering in Healthcare (FHIES/SEHC 2014)}, series = {Lecture Notes in Computer Science}, volume = {9062}, year = {2017}, month = {July}, publisher = {Springer}, organization = {Springer}, address = {Washington, DC, USA}, 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.

}, attachments = {https://haslab.uminho.pt/sites/default/files/jccampos/files/harrison-fhies14.pdf}, author = {Michael Harrison and Paolo Masci and Jos{\'e} Creissac Campos and Paul Curzon} }