Automated Safety Systems Engineering for Focused Ultrasound Medical Devices

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Focused ultrasound is a revolutionary non-invasive surgical approach that uses ultrasound energy to precisely destroy tissue deep in the body without incisions or damage to surrounding tissues. It can be used to treat a broad range of medical conditions, with the potential to offer faster recovery, decreased side effects and reduced cost-of-care compared to traditional surgical methods. Focused ultrasound medical devices are complex and software intensive; moreover, they are safety critical, and significant steps must be taken to ensure their reliability, robustness and safety. This project aims to develop new software and safety engineering techniques to both improve the productivity of software developers of focused ultrasound medical devices and help ensure that the ultimate product is safe and can be certified as such in compliance with relevant medical standards. By addressing the technical challenges and very significant costs of certification, this project will develop techniques that will not only enable substantial improvements in the safety of software-intensive medical devices, but will also benefit the Canadian medical device industry, and in particular small-to-medium sized companies, for whom the cost of certification is a tremendous financial burden and risk.