实现欧盟人工智能医疗设备生命周期的合规性：行业视角

arXiv - CS - Software Engineering Pub Date : 2024-09-12 DOI:arxiv-2409.08006

Tuomas Granlund, Vlad Stirbu, Tommi Mikkonen

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引用次数: 0

摘要

尽管人工智能驱动的医疗设备在医疗保健领域具有巨大的变革潜力，但人们对其在生命攸关的应用中的安全性仍然存在担忧。虽然欧洲的监管框架为医疗设备软件开发提供了一种全面的方法，但在解决人工智能的具体问题方面却存在不足。本文提出了一个模型，通过扩展人工智能生命周期的一般概念，将与人工智能医疗系统相关的监管活动纳入其中，从而弥补这一不足。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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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.

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arXiv - CS - Software Engineering

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