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RISRegulatory Challenges in AI/ML-Enabled Medical Devices: A Scoping Review and Conceptual Framework
Publisher: The American Society of Mechanical Engineers (ASME)
Abstract: Amidst rapid advancements in artificial intelligence and machine learning-enabled medical devices (AI/ML-MD), this article investigates the regulatory challenges highlighted in the current academic literature. Using a ...
Regulatory Challenges in AI/ML-Enabled Medical Devices: A Scoping Review and Conceptual Framework
Publisher: The American Society of Mechanical Engineers (ASME)
Abstract: Amidst rapid advancements in artificial intelligence and machine learning-enabled medical devices (AI/ML-MD), this article investigates the regulatory challenges highlighted in the current academic literature. Using a ...