1
Structure the complaint
The agent extracts the event, device, patient impact, dates, missing information, and source references.
Medical-device complaint operations
Clear complaint backlogs faster without letting AI make the reportability decision.
The agent structures each complaint, applies your decision tree, and drafts the rationale. Your authorized reviewer decides. Every case retains the evidence needed to reconstruct what happened.
2
Apply your decision tree
It drafts a reportability rationale against your controlled procedure and flags uncertainty or missing evidence.
3
Stop for the authorized reviewer
The agent cannot make or approve the consequential reportability decision. A named reviewer owns it.
4
Retain the complete record
Inputs, policy version, recommendation, reviewer decision, reason, and outcome remain linked in a tamper-evident evidence pack.
Start with evidence, not procurement
Evaluate historical cases first.
Use a synthetic or minimized historical set. Compare the agent's triage and rationale with the recorded adjudication, inspect every disagreement, and measure reviewer workload.
The evaluation should answer four questions: how much preparation time is removed, which cases escalate, whether the reviewer has sufficient context, and whether the retained record is useful to quality and audit.
Your QMS remains the system of record. MakerChecker governs the agent action and produces the linked evidence; it does not replace complaint handling procedures or human judgment.
Workflow assessment
Find out whether this is worth a pilot.
Score the current controls, name the exact consequential action, and send the result for a focused review before discussing implementation.
Assess complaint triage