AURA 9 - TOOLS

1. Ensure Actor Registration & SRN Oversight 2. Ensure UDI & Device Registration Compliance 3. Ensure Notified Body & Certificate Data (if applicable) 4. Ensure Vigilance & PMS Data Accuracy 5. Ensure Clinical / Performance Data Consistency 6. Ensure Data Integrity & Compliance Control 7. Ensure Change Management 8. Ensure Coordination with Authorized Representative 9. Ensure Audit & Inspection Readiness