Maintain · MedoQi AI Solutions
IntelliVigilance AI™
Manage Intelligently. Comply Confidently. Complaint intake, IMDRF coding, jurisdictional reportability support and trend monitoring, with decisions made and recorded by people.
The problem
Complaint volumes grow faster than teams. Coding is inconsistent, reportability decisions are made under time pressure, and trends surface late.
Typical inputs
- Complaint records from every channel
- Product, risk and IFU information
- Country of occurrence
- History of similar events
Outputs
- Coded complaint records
- Reportability recommendation with rationale, per jurisdiction
- Draft regulatory report content
- Trend data for PMS reporting
Workflow
Five steps, one record
- 01Complaint intakeCaptured from all sources into one controlled record.
- 02Triage and codingIMDRF terms suggested, seriousness assessed.
- 03Reportability reviewRecommendation by jurisdiction, with the clock that applies.
- 04Regulatory reportingReport content prepared for submission.
- 05Trending and CAPASignals fed into trend reports, CAPA and the risk file.
Human review control
Reportability recommendations are reviewed by a specialist. The manufacturer makes and owns the final decision and keeps its legal reporting obligations.
Illustrative record · fictitious event
- Complaint
- Catheter tip separated during insertion. Fragment retrieved; no patient injury.
- Occurred in
- Germany; same lot also distributed in the US
- Device problem
- IMDRF Annex A term suggested: component separation
- Health effect
- No health consequence reported
- EU
- Recommend: serious incident (could have led to serious deterioration), report within 15 days
- US
- Recommend: reportable malfunction, 30-day report
- Decision
- Awaiting specialist review
Talk to our experts
Discuss your device, market or audit with a specialist
Share the device, its class and your target markets. A senior specialist will come back with the likely pathway, the evidence gaps we see and a practical plan.