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arXiv · 2409.08006

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

Tuomas Granlund·Vlad Stirbu·Tommi Mikkonen
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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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Tuomas Granlund, Vlad Stirbu, Tommi Mikkonen. 2024-09-12. Towards regulatory compliant lifecycle for AI-based medical devices in EU: Industry perspectives. https://doi.org/10.1109/mc.2024.3414368

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