medical device classification
AI for Regulatory Affairs: Balancing Accuracy, Interpretability, and Computational Cost in Medical Device Classification
Han, Yu, Ceross, Aaron, Bergmann, Jeroen H. M.
Regulatory affairs, which sits at the intersection of medicine and law, can benefit significantly from AI-enabled automation. Classification task is the initial step in which manufacturers position their products to regulatory authorities, and it plays a critical role in determining market access, regulatory scrutiny, and ultimately, patient safety. In this study, we investigate a broad range of AI models -- including traditional machine learning (ML) algorithms, deep learning architectures, and large language models -- using a regulatory dataset of medical device descriptions. We evaluate each model along three key dimensions: accuracy, interpretability, and computational cost.
Leveraging Machine Learning for Medical Device Classifications & Behavioral Analyses
Hospitals are on the radar of hackers as "soft" and valuable targets. The modern medical facility is connected to the internet in a multitude of ways. These connections include email clients, multi-location data integration systems, medical devices, and off-premise vendor support; all which leave hospitals and clinical networks extremely vulnerable to attack.