Static analysis of medical device software using CodeSonar
Proceedings of the 2008 workshop on Static analysis
Model-Based Testing of GUI-Driven Applications
SEUS '09 Proceedings of the 7th IFIP WG 10.2 International Workshop on Software Technologies for Embedded and Ubiquitous Systems
Toward patient safety in closed-loop medical device systems
Proceedings of the 1st ACM/IEEE International Conference on Cyber-Physical Systems
A framework for the safe interoperability of medical devices in the presence of network failures
Proceedings of the 1st ACM/IEEE International Conference on Cyber-Physical Systems
Innovations in Systems and Software Engineering
Safety-assured development of the GPCA infusion pump software
EMSOFT '11 Proceedings of the ninth ACM international conference on Embedded software
Model-based dependability analysis of programmable drug infusion pumps
FORMATS'11 Proceedings of the 9th international conference on Formal modeling and analysis of timed systems
On software certification: we need product-focused approaches
Monterey'08 Proceedings of the 15th Monterey conference on Foundations of Computer Software: future Trends and Techniques for Development
Design challenges for secure implantable medical devices
Proceedings of the 49th Annual Design Automation Conference
Timed relational abstractions for sampled data control systems
CAV'12 Proceedings of the 24th international conference on Computer Aided Verification
Computers in Biology and Medicine
Towards trustworthy medical devices and body area networks
Proceedings of the 50th Annual Design Automation Conference
| Hi-index | 0.00 |
As software becomes ever more ubiquitous and complex in medical devices, it becomes increasingly important to assure that it performs safely and effectively. The critical nature of medical devices necessitates that the software used therein be reliable and free of errors. It becomes imperative, therefore, to have a conformance review process in place to ascertain the correctness of the software and to ensure that it meets all requirements and standards. Formal methods have long been suggested as a means to design and develop medical device software. However, most manufacturers shy from using these techniques, citing them as too complex and time consuming. As a result, (potentially life-threatening) errors are often not discovered until a device is already on the market. In this paper we present a reference model based approach to software conformance checking. Reference models enable the application of formal methods to software conformance checking, and provide a framework for rigorous testing. To illustrate the approach, we develop the reference model for a Generic Patient Controlled Analgesic Infusion Pump, and explain how it can be used to aid software conformance checking in a regulatory environment.