Departmental Papers (CIS)
Document Type
Conference Paper
Date of this Version
10-2011
Abstract
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.
Keywords
Verification, Legal aspects, Medical cyber-physical systems, certification, assurance cases, virtual medical devices, PRECISE_paper, PRECISE_CPS_Medical
Date Posted: 19 January 2012
This document has been peer reviewed.
Comments
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, http://doi.acm.org/10.1145/2038642.2038677