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Full-Text Articles in Physical Sciences and Mathematics
Challenges In The Regulatory Approval Of Medical Cyber-Physical Systems, Oleg Sokolsky, Insup Lee, Mats Heimdahl
Challenges In The Regulatory Approval Of Medical Cyber-Physical Systems, Oleg Sokolsky, Insup Lee, Mats Heimdahl
Oleg Sokolsky
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.
Safety-Critical Medical Device Development Using The Upp2sf Model, Miroslav Pajic, Zhihao Jiang, Insup Lee, Oleg Sokolsky, Rahul Mangharam
Safety-Critical Medical Device Development Using The Upp2sf Model, Miroslav Pajic, Zhihao Jiang, Insup Lee, Oleg Sokolsky, Rahul Mangharam
Oleg Sokolsky
Software-based control of life-critical embedded systems has become increasingly complex, and to a large extent has come to determine the safety of the human being. For example, implantable cardiac pacemakers have over 80,000 lines of code which are responsible for maintaining the heart within safe operating limits. As firmware-related recalls accounted for over 41% of the 600,000 devices recalled in the last decade, there is a need for rigorous model-driven design tools to generate verified code from verified software models. To this effect we have developed the UPP2SF model-translation tool, which facilitates automatic conversion of verified models (in UPPAAL) to …