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| Autores principales: | , , |
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| Formato: | Preprint |
| Publicado: |
2025
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| Materias: | |
| Acceso en línea: | https://arxiv.org/abs/2506.18511 |
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| _version_ | 1866911019014553600 |
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| author | Han, Yu Ceross, Aaron Bergmann, Jeroen H. M. |
| author_facet | Han, Yu Ceross, Aaron Bergmann, Jeroen H. M. |
| contents | Identifying the appropriate regulatory standard applicability remains a critical yet understudied challenge in medical device compliance, frequently necessitating expert interpretation of fragmented and heterogeneous documentation across different jurisdictions. To address this challenge, we introduce a modular AI system that leverages a retrieval-augmented generation (RAG) pipeline to automate standard applicability determination. Given a free-text device description, our system retrieves candidate standards from a curated corpus and uses large language models to infer jurisdiction-specific applicability, classified as Mandatory, Recommended, or Not Applicable, with traceable justifications. We construct an international benchmark dataset of medical device descriptions with expert-annotated standard mappings, and evaluate our system against retrieval-only, zero-shot, and rule-based baselines. The proposed approach attains a classification accuracy of 73% and a Top-5 retrieval recall of 87%, demonstrating its effectiveness in identifying relevant regulatory standards. We introduce the first end-to-end system for standard applicability reasoning, enabling scalable and interpretable AI-supported regulatory science. Notably, our region-aware RAG agent performs cross-jurisdictional reasoning between Chinese and U.S. standards, supporting conflict resolution and applicability justification across regulatory frameworks. |
| format | Preprint |
| id |
arxiv_https___arxiv_org_abs_2506_18511 |
| institution | arXiv |
| publishDate | 2025 |
| record_format | arxiv |
| spellingShingle | Standard Applicability Judgment and Cross-jurisdictional Reasoning: A RAG-based Framework for Medical Device Compliance Han, Yu Ceross, Aaron Bergmann, Jeroen H. M. Artificial Intelligence Identifying the appropriate regulatory standard applicability remains a critical yet understudied challenge in medical device compliance, frequently necessitating expert interpretation of fragmented and heterogeneous documentation across different jurisdictions. To address this challenge, we introduce a modular AI system that leverages a retrieval-augmented generation (RAG) pipeline to automate standard applicability determination. Given a free-text device description, our system retrieves candidate standards from a curated corpus and uses large language models to infer jurisdiction-specific applicability, classified as Mandatory, Recommended, or Not Applicable, with traceable justifications. We construct an international benchmark dataset of medical device descriptions with expert-annotated standard mappings, and evaluate our system against retrieval-only, zero-shot, and rule-based baselines. The proposed approach attains a classification accuracy of 73% and a Top-5 retrieval recall of 87%, demonstrating its effectiveness in identifying relevant regulatory standards. We introduce the first end-to-end system for standard applicability reasoning, enabling scalable and interpretable AI-supported regulatory science. Notably, our region-aware RAG agent performs cross-jurisdictional reasoning between Chinese and U.S. standards, supporting conflict resolution and applicability justification across regulatory frameworks. |
| title | Standard Applicability Judgment and Cross-jurisdictional Reasoning: A RAG-based Framework for Medical Device Compliance |
| topic | Artificial Intelligence |
| url | https://arxiv.org/abs/2506.18511 |