RegDesk
AI Bot Training Environment
1
Use Case Selection
2
Input & Execution
3
Feedback & Refinement

Select Training Use Case

Choose a regulatory workflow to train the AI assistant

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AI Assistant
RegDesk Data Intelligence · Ask anything about regulatory data
Ready

Hi! I'm the RegDesk AI Assistant. Ask me anything about regulatory data, submissions, country requirements, trackings — or any of the tools I have access to.

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Files
Reports and outputs generated by AI Assistant, AI Training, and MDA modules
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📄 MDA XML Templates

Generate and validate EUDAMED XML submissions for EU medical device registration (MDR/IVDR).


🔍 Validate XML File

Upload an XML file to validate it against EUDAMED XSD schemas.


🧭 Which XML do I need?

Select your update scenario to get the recommended XML type and service.

ℹ️ About EUDAMED XML: These templates follow the DTX (Data Transfer Exchange) schema for EUDAMED M2M submissions. Replace all placeholders before submitting. Schemas: EUDAMED DTX Service

🔧 Template Feedback & Patch

Upload an .xlsx file with two columns: Current (text to find) and Fix (replacement text). Review the changes, select which ones to apply, then patch the templates.

🔍 EUDAMED Device Intelligence

Search EU & FDA regulatory databases — device records, identifiers, certificates & dossiers

Resolve Any Regulatory Identifier

Resolves to the canonical regulatory record. Try: K213001  ·  00884728918744  ·  SRN/DE/…

Full Device Dossier
FDA ↔ EU Cross-Reference
⚠️ Advisory only — results are candidate matches, not equivalence determinations.
Manufacturer Lookup

Enter a company name (e.g. Medtronic) to search, or an SRN (e.g. SRN/DE/000012345) for a full profile.

Certificate Verification

Returns certificate validity, notified body, scope, and linked devices.