Date of this Version
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
Oleg Sokolsky, Insup Lee, and Mats Heimdahl, "Challenges in the Regulatory Approval of Medical Cyber-Physical Systems", . October 2011.
Date Posted: 19 January 2012
This document has been peer reviewed.