Engineering high confidence medical device software

Authors:
Arnab Ray;Raoul Jetley;Paul Jones
Affiliations:
Fraunhofer Center for Experimental Software Engineering;US Food and Drug Administration, Center for Devices and Radiological Health;US Food and Drug Administration, Center for Devices and Radiological Health
Venue:
ACM SIGBED Review - Special Issue on the 2nd Joint Workshop on High Confidence Medical Devices, Software, and Systems (HCMDSS) and Medical Device Plug-and-Play (MD PnP) Interoperability
Year:
2009

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Abstract

The increasing complexity of medical device software has created new challenges in ensuring that a medical device operates correctly. This paper discusses how two technologies---model-based development and static analysis---may be used to facilitate the successful engineering of medical software and some possible regulatory side benefits.