7 papers
Measuring Cross-Jurisdictional Transfer of Medical Device Risk Concepts with Explainable AI
Yu Han, Aaron Ceross
Medical device regulators in the United States(FDA), China (NMPA), and Europe (EU MDR) all use the language of risk, but classify devices through structurally different mechanisms.…
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…
Regulator-Manufacturer AI Agents Modeling: Mathematical Feedback-Driven Multi-Agent LLM Framework
Yu Han, Zekun Guo
The increasing complexity of regulatory updates from global authorities presents significant challenges for medical device manufacturers, necessitating agile strategies to sustain…
Transforming Medical Regulations into Numbers: Vectorizing a Decade of Medical Device Regulatory Shifts in the USA, EU, and China
Yu Han, Jeroen Bergmann
Navigating the regulatory frameworks that ensure the safety and efficacy of medical devices can be challenging, especially across different regions. These frameworks often require…