Forensic Analysis of Medical Devices

该奖项在美国食品和药物管理局建立了一个NSF-FDA驻校学者（SIR）项目。 在NSF的支持下，来自北卡罗来纳州州立大学的两名研究生将参加一个研究项目，在FDA的器械和放射健康研究中心研究医疗器械评估技术。 该SIR项目有助于实现NSF和FDA共同的目标，即为软件密集型医疗设备中的嵌入式系统提供技术支持的严格评估方法。 本研究的重点是将NCSU开发的C-Wolf数据抽象和软件分析工具应用于医疗器械软件。 这是探索软件分析工具在批准前器械评估和事件后取证分析中的实用性的整体努力的一部分。 NSF-FDA SIR项目的长期目标是为医疗器械和其他安全关键型、以软件为中心的系统的评价提供更全面、基于证据的方法。

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.