AI Tools Overview
Reguverse includes multiple AI-powered tools for daily regulatory work. Access them via the "AI Tools" icon in the bottom navigation.
Available Tools
MDR/IVDR Device Classification
Classify medical devices according to EU MDR Annex VIII or EU IVDR Annex VIII rules.
- Supports MDR (Class I/IIa/IIb/III) and IVDR (A/B/C/D)
- Based on MDCG 2021-24 guidance verification
- Outputs classification rationale with regulatory references
Available on: All plans
Equivalent Device Research
Identify and evaluate equivalent devices using FDA 510(k) databases and web research.
- Automatic FDA 510(k) database search
- Clinical, technical, and biological equivalence analysis
- Structured equivalence argumentation output
Available on: All plans
Document Translation
AI translation optimized for medical device regulatory documents.
- Chinese-English bidirectional translation
- In-place Word document translation (preserves formatting)
- Excel batch translation support
- Medical device terminology accuracy
Available on: All plans
EUDAMED UDI Bulk Upload
Batch generate EUDAMED XML files for manufacturers with many UDI-DI codes.
- Excel data import (custom format + standard template)
- EUDAMED XSD v3.0.28 compliant XML generation
- Automatic file splitting (40 identifiers per file)
- ZIP download package
Available on: All plans