Toward a Regulatory-Compliant Lifecycle for Artificial-Intelligence-Based Medical Devices in the European Union : Industry Perspectives
Granlund, T., Stirbu, V., & Mikkonen, T. (2024). Toward a Regulatory-Compliant Lifecycle for Artificial-Intelligence-Based Medical Devices in the European Union : Industry Perspectives. Computer, 57(9), 24-34. https://doi.org/10.1109/mc.2024.3414368
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Despite the immense potential of artificial intelligence (AI)-powered medical devices to revolutionize health care, concerns regarding their safety in life-critical applications remain. This article proposes extending the general idea of AI lifecycle with regulatory activities relevant to AI-enabled medical systems.
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