Challenges in the Regulatory Approval of Medical Cyber-Physical Systems

Loading...
Thumbnail Image
Penn collection
Departmental Papers (CIS)
Degree type
Discipline
Subject
CPS Medical
Verification
Legal aspects
Medical cyber-physical systems
certification
assurance cases
virtual medical devices
Software Engineering
Funder
Grant number
License
Copyright date
Distributor
Related resources
Contributor
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.

Advisor
Date of presentation
2011-10-01
Conference name
Departmental Papers (CIS)
Conference dates
2023-05-17T06:58:48.000
Conference location
Date Range for Data Collection (Start Date)
Date Range for Data Collection (End Date)
Digital Object Identifier
Series name and number
Volume number
Issue number
Publisher
Publisher DOI
Journal Issue
Comments
International Conference on Embedded Software (EMSOFT 2011), Taipei, Taiwan, October 2011.
Recommended citation
Collection