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

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arxiv 2409.08006 v1 pith:CHDGGFK4 submitted 2024-09-12 cs.SE

Tuomas Granlund , Vlad Stirbu , Tommi Mikkonen This is my paper · ORCID
classification cs.SE
keywords medicalregulatorydeviceslifecycleactivitiesaddressingai-basedai-enabled
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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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