Towards regulatory compliant lifecycle for AI-based medical devices in EU: Industry perspectives
<|reference_start|>Towards regulatory compliant lifecycle for AI-based medical devices in EU: Industry perspectives: 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.<|reference_end|>
@article{granlund2024towards,
    title={Towards regulatory compliant lifecycle for AI-based medical devices in
  EU: Industry perspectives},
    author={Tuomas Granlund, Vlad Stirbu, Tommi Mikkonen},
    journal={arXiv preprint arXiv:2409.08006},
    year={2024},
    doi={10.1109/MC.2024.3414368},
    archivePrefix={arXiv},
    eprint={2409.08006},
    primaryClass={cs.SE}
}