5 citations · 9 across the 10 of their papers we have counts for
3 papers · 1 filter
Standard Applicability Judgment and Cross-jurisdictional Reasoning: A RAG-based Framework for Medical Device Compliance
Yu Han, Aaron Ceross, Jeroen H. M. Bergmann
Identifying the appropriate regulatory standard applicability remains a critical yet understudied challenge in medical device compliance, frequently necessitating expert interpreta…
AI for Regulatory Affairs: Balancing Accuracy, Interpretability, and Computational Cost in Medical Device Classification
Yu Han, Aaron Ceross, Jeroen H. M. Bergmann
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 manuf…
Toward Automated Regulatory Decision-Making: Trustworthy Medical Device Risk Classification with Multimodal Transformers and Self-Training
Yu Han, Aaron Ceross, Jeroen H. M. Bergmann
Accurate classification of medical device risk levels is essential for regulatory oversight and clinical safety. We present a Transformer-based multimodal framework that integrates…