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FDA regulated medical devices are considered safety-critical systems due to their ability to affect patient lives. Given the nature of scrutiny and the requirement to play it safe, most medical device vendors end up choosing proprietary or custom solutions for operating systems, databases, messaging platforms, alarm notification systems, and event logging.
This talk uncovered some of the common misconceptions around government regulations and how there are not inherent limitations around using FOSS in safety-critical systems so long as the requisite risk analysis and quality assurance work is conducted.
Shahid presented his recent work on modern medical device architectures, the challenges and opportunities associated with using open source software in medical devices, and real-world findings from use of open source answering questions such as:
Will the FDA accept open source in safety-critical systems?
Are open source systems safe enough for medical devices?
What kind of assessments are needed for open source software in medical devices?