Regulatory LLM · Pharma & Medical Device
Complaint Handling · On Autopilot

No more complaints piling up. Your secure AI agents clear the queue 24/7.

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Run your tailor-made agents on your real complaints. All of them.

30-minute demo · Zero commitment · We reply within 24h

Runs on your actual complaint data
Data stays inside your environment
LIVE QUEUE
Auto-prioritized by severity & reportability
4,217 open · awaiting sign-off
1,892 filed on time today
CRITICAL Implant · death during procedure (DE) EU MDR Art. 87(5) · 10-day
CRITICAL Sterility breach · distributed lot EU MDR Art. 87(4) · 2-day
CRITICAL Overheating · remedial action needed FDA 21 CFR 803.53 · 5-day
HIGH Infusion pump · under-delivery, alarm fail FDA 21 CFR 803.50 · 30-day
HIGH Autoinjector · failed actuation 21 CFR Part 4 · combination
MEDIUM Software correction · fielded units FDA 21 CFR Part 806 · FSCA
MEDIUM IVD reagent · incorrect-result risk EU IVDR Art. 82 · 15-day
LOW Packaging defect · no performance impact ISO 13485 8.2.2 · QMSR
Received Triaged Narrative Sign-off Filed ✓
Generated narrative · illustrative sample
Infusion pump under-delivered during therapy; occlusion alarm did not activate. No patient harm. Assessed as a reportable malfunction under 21 CFR 803.50; MDR filed ≤30 days. CAPA investigation ongoing.
01

What changes

Today
A backlog your team can't clear.
→
With the agents
Intaked, coded, and triaged the second it lands. Nothing waits for a human.
Today
Reportability calls that won't survive an audit.
→
With the agents
Your decision tree, run on every event. Every MDR and MIR deadline held, every market.
Today
Narratives nobody has time to write.
→
With the agents
Drafted in seconds, you sign off. Full audit trail, inspection-ready.
02

What you get back

95%
of the work runs on the agents. Your team just reviews, approves, and signs off on the results.
Days → min
From intake to a reviewed, ready-to-file narrative.
Same team
Complaint volume climbs. Your headcount doesn't.
Outcome-based: you pay for complaints closed, not for seats.