Certification of Medical Device Software

提案编号：0820245标题：医疗器械软件认证PI：Jens Palsberg Co-PI：Majid Sarrafzadeh医疗器械不应崩溃或混淆。设备崩溃可能是从不便到危及生命的任何事情，而混乱的设备行为可能导致用户得出错误的医疗结论。虽然严格的测试仍然是必不可少的，但设计、实施和认证的新方法具有极大的潜力，可以提高我们对医疗器械的信心。在这个研究领域的彩虹的尽头，是一个可认证性设计的范例，程序员从第一天开始就考虑认证，并创建可以通过静态错误检查工具认证的设计和代码。该项目的目标是开发语言和工具，以优雅而强大的新方式设计，构建和认证医疗设备软件。该项目的重点是一类常见的医疗设备，称为医疗监测设备。研究人员设想了一种认证工具，可以满足与空间界限，软实时响应，寿命和有意义的结果相关的挑战。该项目的目标是朝着可认证性设计迈出重要一步，并使FDA经常和定期使用静态错误检查工具的日子更近一步。该项目的成果之一将是医疗设备软件的开源版本，沿着新语言和认证工具的实现。其结果是一个试验医疗设备软件的平台，可能为研究人员开辟新的可能性。

Proposal number: 0820245Title: Certification of Medical Device SoftwarePI: Jens PalsbergCo-PI: Majid SarrafzadehA medical device should not crash or confuse. A device crash can be anything from inconvenient to life threatening, while confusing device behavior can lead a user to draw an incorrect medical conclusion. While rigorous testing will remain essential, new approaches to design, implementation, and certification have great potential to increase our confidence in medical devices. At the end of the rainbow in this research area lays a design for certifiability paradigm in which programmers think of certification from day one and create designs and code that can be certified by static error checking tools. The project's goal is to develop languages and tools for designing, building, and certifying medical device software in elegant and powerful new ways. The project focuses on a common class of medical devices called medical monitoring devices. The investigators envision a certification tool that can meet challenges related to space bounds, soft-real-time response, life time, and meaningful results. The project's goal is to take a major step towards design for certifiability and to bring closer the day when the FDA will use static error checking tools frequently and routinely. One of the outcomes of the project will be open-source versions of medical device software, along with implementations of the new language and certification tools. The result is a platform for experimenting with software for medical devices that may open up new possibilities for researchers.