Overview
Not every reported issue turns out to be a complaint. The Medical Device Complaint Packaging and Analysis Agent assesses the complainant's original report and the technician's resolution together once both are finalized, testing the combined record against the manufacturer's configured complaint criteria. Some cases clear the bar; some don't. What looked like a serious event at intake sometimes resolves as routine, non-reportable maintenance. Either way, the finding is cited to specific evidence. The determination stays with Quality, who sees every case; what changes is how prepared the record is when it reaches them.
Capabilities
Assemble intake and resolution into a single structured package
Combines the complainant's report and the technician's resolution into one record organized for Quality review.
Assess the package against ISO 13485 complaint criteria
Tests the combined record against the manufacturer's configured complaint-handling rubric across all required dimensions.
Cite the evidence behind each finding
Every finding ties back to a customer quote, technician note, or confirmed Pathways reference. Nothing is asserted without a source.
Separate routine maintenance from complaint-reportable findings
Cases that resolve as non-reportable maintenance are distinguished from those that meet the complaint bar. The determination stays with Quality.
Example use case
User input
SR-2026-100442 ready for complaint assessment. Intake and resolution both complete.
Agent summary
- Patient exposure: confirmed — patient connected during event
- Malfunction during use: confirmed — abnormal behavior reported by clinical staff
- Serious injury potential: requires Quality determination — smoke and odor reported, eye irritation noted
- Resolution documentation: complete — root cause confirmed, corrective action taken, return-to-service verified
Flagged by agent
Agent handoff
Quality review package ready:
- Complaint determination: meets criteria — Quality to confirm reportability
- Evidence cited to customer verbatim, technician notes, and Pathways reference
- Package organized for regulatory review
Agent workflow
1. Intake and resolution records arrive complete
Both have already been checked by the intake and resolution compliance agents.
2. Combined package assessed against the configured complaint criteria
The intake and resolution records are tested against the manufacturer's complaint-handling rubric.
3. Narratives compared and evidence cited
Each finding ties back to a customer quote, technician note, or confirmed Pathways reference.
4. Agent prepares the analysis package
The contents are organized for Quality review with findings, evidence, and open questions clearly separated.
5. Package surfaced to Quality with determination and cited evidence
Quality reviews a prepared record with the complaint assessment already complete. The determination is theirs; the preparation is the agent's.
