Departmental Papers (CIS)

Document Type

Conference Paper

Subject Area

CPS Medical

Date of this Version



In Proceedings of the International Conference on Embedded Software (EMSOFT 2011). Taipei, Taiwan, October 2011.

© ACM, 2011. This is the author's version of the work. It is posted here by permission of ACM for your personal use. Not for redistribution. The definitive version was published in EMSOFT '11 Proceedings of the ninth ACM international conference on Embedded software,


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.


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


Date Posted: 19 January 2012

This document has been peer reviewed.