2 citations · 4 across the 8 of their papers we have counts for
8 papers
Finite Audits of Model Updating: Coverage and Resolution of Paired Disparity Comparisons
Aaron Ceross
Finite audits can become more precise and decisive without reliably covering the change in subgroup disparity. We study the updating-minus-frozen difference in absolute subgroup ga…
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…
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…
Data-Driven Analysis of AI in Medical Device Software in China: Trends of Deep Learning and Traditional AI Based on Regulatory Data
Yu Han, Aaron Ceross, Sarim Ather +1
Artificial intelligence (AI) in medical device software (MDSW) represents a transformative clinical technology, attracting increasing attention within both the medical community an…
Uncovering Regulatory Affairs Complexity in Medical Products: A Qualitative Assessment Utilizing Open Coding and Natural Language Processing (NLP)
Yu Han, Aaron Ceross, Jeroen H. M. Bergmann
This study investigates the complexity of regulatory affairs in the medical device industry, a critical factor influencing market access and patient care. Through qualitative resea…