面向欧盟AI类医疗器械的合规生命周期：行业视角
Towards regulatory compliant lifecycle for AI-based medical devices in EU: Industry perspectives
AI总结：
针对欧盟现有医疗器械监管框架未覆盖AI特有考量的问题，本文提出拓展AI生命周期、融入AI医疗系统相关监管活动的模型，以填补AI类医疗器械合规性空白。
摘要：
尽管AI驱动的医疗器械拥有革新医疗保健的巨大潜力，但其在生命关键应用中的安全性仍存隐忧。欧洲监管框架虽为医疗器械软件开发提供了全面方案，却未能覆盖AI特有的考量因素。本文提出一种模型，通过将AI生命周期的通用思路拓展至结合AI赋能医疗系统相关的监管活动，以填补这一空白。
英文摘要：
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.
机构、总结、中文摘要均由AI分析而来，可能存在错误，请以论文正文为准。
