Departmental Papers (CIS)

Date of this Version


Document Type

Conference Paper


International Conference on Embedded Software (EMSOFT 2011), Taipei, Taiwan, October 2011.


We are considering the challenges that regulators face in approving modern medical devices, which are software intensive and increasingly network enabled. We then consider assurance cases, which o er the means of organizing the evidence into a coherent argument demonstrating the level of assurance provided by a system, and discuss research directions that promise to make construction and evaluation of assurance cases easier and more precise. Finally, we discuss some recent trends that will further complicate the regulatory approval of medical cyber-physical systems.

Subject Area

CPS Medical

Publication Title

International Conference on Embedded Software (EMSOFT 2011)

First Page


Last Page




Permission Statement

© ACM 2011. This is the author's version of the work. It is posted here for your personal use. Not for redistribution. The definitive Version of Record was published in Proceedings of the International Conference on Embedded Software (EMSOFT 2011),


Verification, Legal aspects, Medical cyber-physical systems, certification, assurance cases, virtual medical devices


Date Posted: 19 January 2012

This document has been peer reviewed.