Date of this Version
Oleg Sokolsky, Insup Lee, and Mats Heimdahl, "Challenges in the Regulatory Approval of Medical Cyber-Physical Systems", International Conference on Embedded Software (EMSOFT 2011) , 227-232. October 2011. http://dx.doi.org/10.1145/2038642.2038677
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.
International Conference on Embedded Software (EMSOFT 2011)
© 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), http://dx.doi.org/10.1145/2038642.2038677.
Verification, Legal aspects, Medical cyber-physical systems, certification, assurance cases, virtual medical devices
Date Posted: 19 January 2012
This document has been peer reviewed.