2 citations · 3 across the 4 of their papers we have counts for
4 papers
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…
The Use of Readability Metrics in Legal Text: A Systematic Literature Review
Yu Han, Aaron Ceross, Jeroen H. M. Bergmann
Understanding the text in legal documents can be challenging due to their complex structure and the inclusion of domain-specific jargon. Laws and regulations are often crafted in s…