Towards regulatory compliant lifecycle for AI-based medical devices in EU: Industry perspectives

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Authors Tuomas Granlund, Vlad Stirbu, Tommi Mikkonen arXiv ID 2409.08006 Category cs.SE: Software Engineering Citations 0 Venue Computer Last Checked 5 months ago
Abstract
Despite the immense potential of AI-powered medical devices to revolutionize healthcare, concerns regarding their safety in life-critical applications remain. While the European regulatory framework provides a comprehensive approach to medical device software development, it falls short in addressing AI-specific considerations. This article proposes a model to bridge this gap by extending the general idea of AI lifecycle with regulatory activities relevant to AI-enabled medical systems.
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