MDR Bot Expert

Welcome to the MDR Bot Expert!

I am a fully local expert system powered by the comprehensive medical device regulatory information stored in your repository — including **ISO 13485:2016** and **ISO 14971:2019** standard specifications.

No data leaves this server. I can assist with:

• **QMS / ISO 13485** — Quality management & clauses
• **Risk / ISO 14971** — Benefit-risk & hazard control
• **Device Classification** — MDR rules & classes
• **GSPR Compliance** — Annex I obligations
• **Clinical Evaluation** — CEP/CER & equivalence
• **PMS, PSUR, and EUDAMED** — Reporting requirements

Type your regulatory query below.