Forensic Analysis of Medical Devices

North Carolina State University, Raleigh NC

Investigators

Abstract

This award establishes a NSF-FDA Scholar-in-Residence (SIR) project at the U.S. Food and Drug Administration. With NSF support, two graduate students from North Carolina State University will participate in a research project to study technology for medical device evaluation at the FDA's Center for Research in Devices and Radiological health. This SIR project contributes towards the goal shared by NSF and the FDA of technology-supported, rigorous evaluation methods for embedded systems in software-intensive medical devices. This research focuses on applying the C-Wolf data abstraction and software analysis tool, developed at NCSU, to medical device software. This is part of an overall effort to explore the utility of software analysis tools in pre-approval device evaluation and post-incident forensic analysis. The longer-term goal of NSF-FDA SIR projects is to enable a more comprehensive, evidence-based approach for evaluation of medical devices and other safety-critical, software-centric systems.