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AI Complaint, Reportability & FSCA Workpaper
Organize an incident into traceable facts, unknowns, health-risk questions, potential reporting paths and field-action options across the markets you name. Patient-identifying information should never be pasted.
Free · no loginStructured outputPaste up to 50,000 charactersCurrent-source checks when useful
Paste the incident facts, investigation, risk evidence and markets
Try an example
Remove patient identifiers. Include dates, device identifiers, outcome, malfunction, returned-device findings, similar events, distributed scope, risk-file information, and every market in scope.
Separate documents with headings when possible. Do not paste patient-identifying information.0 / 50,000
Privacy: Pure Global does not publish this pasted text or generated workpaper. It is processed for this review and sent to our AI provider. Avoid patient-identifying information and confidential material you are not authorized to share.
About this agent
What to paste for a useful review
Remove names, medical-record numbers and other patient identifiers. Include the awareness date, event, outcome, device identifiers and market.
Add returned-device evidence, prior complaints, distribution scope, health-risk analysis, CAPA status and any proposed customer or authority action.
- Can the tool decide whether an event is reportable?
- No. It identifies possible reporting paths, missing facts and decisions requiring current official-rule review. The accountable manufacturer makes and documents the final determination.
- Can I include several markets?
- Yes. Name only markets actually in scope and include local representative or sponsor information when known.
- Should I paste patient information?
- No. Remove direct and indirect patient identifiers. A regulatory workpaper normally needs the event facts and outcome, not identifying personal data.
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