Towards regulatory compliant lifecycle for AI-based medical devices in EU: Industry perspectives
Fuente:
arXiv
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| Autori principali: | , , |
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| Natura: | Preprint |
| Pubblicazione: |
2024
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| Soggetti: | |
| Accesso online: | |
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| _version_ | 1866912024817041408 |
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| author | Granlund, Tuomas Stirbu, Vlad Mikkonen, Tommi |
| author_facet | Granlund, Tuomas Stirbu, Vlad Mikkonen, Tommi |
| contents | 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. |
| format | Preprint |
| id |
arxiv_https___arxiv_org_abs_2409_08006 |
| institution | arXiv |
| publishDate | 2024 |
| record_format | arxiv |
| spellingShingle | Towards regulatory compliant lifecycle for AI-based medical devices in EU: Industry perspectives Granlund, Tuomas Stirbu, Vlad Mikkonen, Tommi Software Engineering 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. |
| title | Towards regulatory compliant lifecycle for AI-based medical devices in EU: Industry perspectives |
| topic | Software Engineering |
| url | https://arxiv.org/abs/2409.08006 |