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AI agent for regulatory affairs specialists

Post-Market Complaint Reportability Agent

Every complaint assessed for reportability with a deadline before the clock runs out

ComplianceLegal
See how it worksGet access
Post-Market Complaint Reportability Agent: what goes in, what the agent does and what you get

What it does

Some product complaints must be reported to regulators within strict timelines, such as 30 days for many device malfunctions and less for serious injuries. Missing a deadline is a serious finding. This agent reads each new complaint, extracts the event details and checks for death, serious injury or a malfunction that could cause harm. It applies the reporting rules for each market where the product is sold. If facts needed for the decision are missing, it asks the complaint handler and waits, then checks again. Deadlines count from the date the company became aware. It drafts the report fields and searches past reports for similar events. Death or serious injury is escalated the same day. A specialist decides whether to report and submits it. Edge case: similar earlier events are linked so trend reporting can be considered.

How it works

Follow the arrows from top to bottom. The orange dashed arrow is the loop: when a check fails, the agent goes back and tries again.

Start and resultWhat it doesA check on its own workWaits for your OKGoes back and retries
Yes, continueApprovedNo 1 STARTS WHEN New complaint logged 2 USES A TOOL Extract event details from the complaint record 3 DOES Apply reportable event criteria for each market 4 CHECKS THE RESULT Are all facts needed for the decision present? If not: ask the complaint handler for the missing factsand wait. Back to step 2. 5 USES A TOOL Calculate deadlines and draft report fields 6 USES A TOOL Search past reports for similar events 7 YOU APPROVE Specialist decides and submits the report 8 RESULT Reportability decision recorded
Read the steps as a list
  1. New complaint logged
  2. Extract event details from the complaint record
  3. Apply reportable event criteria for each market
  4. Are all facts needed for the decision present?If not: ask the complaint handler for the missing facts and wait. Back to step 2.
  5. Calculate deadlines and draft report fields
  6. Search past reports for similar events
  7. Specialist decides and submits the reportThe agent waits here for your OK.
  8. Reportability decision recorded

How it decides

It applies each market's reportable event criteria to the complaint facts. Missing facts that change the outcome block a decision until filled.

  • Death or serious injury is always escalated the same day
  • Deadlines count from the date the company became aware
  • Similar past events are linked for trend review

Make it yours

Every agent is a starting point. You choose these settings for your own situation.

  • Markets and reporting rules
  • Escalation contacts for serious events
  • Days before deadline to remind (default 7)
  • Similarity rules for linking past events

What keeps you in control

It always asks you first

  • Specialist decides reportability and submits

Hard limits

  • Never submits reports to authorities
  • Never closes a complaint

It stops when

  • Done: decision recorded
  • Stop: complaint closed as not product-related by quality

Set it up

We guide you through the set-up, step by step

Members get the full set-up guide for this agent. No technical skills needed: you copy, paste and upload.

10 minto set it up in your AI
5 AIsChatGPT, Claude, Copilot, Gemini, Grok
  • One set of instructions to paste into your AI, with the clicks for ChatGPT, Claude, Microsoft 365 Copilot, Gemini and Grok
  • The agent then walks you through connecting your own data, one source at a time
  • A downloadable copy with the flow chart, the rules and the full guide
Get access to this agent

An example run

What happensA complaint logged May 2 said an infusion pump alarm failed during use, but whether the patient was harmed was missing. The facts check failed, so the agent asked the handler, who confirmed no injury on May 3. The agent assessed a reportable US malfunction with a 30-day deadline of Jun 1 and linked 2 similar reports from last year. The specialist approved and submitted the report.

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