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.
Free post-market decision workpaper · No signup
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.
Paste up to 50,000 charactersEvidence-first agent workflowBranded A4 report
Build a clean event chronology
The agent separates supplied facts, documents, assumptions and unknowns.
Screen reporting and field-action paths
Every finding stays tied to the evidence you actually supplied.
Connect complaint, risk and CAPA
Turn the result into a practical worklist and save it as a branded PDF.
Build a complaint, reportability and FSCA workpaper
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 save this pasted text or the generated report. The text is sent to our AI provider for this one-time analysis. Avoid confidential information you are not authorized to share.
DJ Fang
MedTech Regulatory Expert
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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.
Continue your regulatory workflow
Move from this workpaper into the next connected review. Pasted evidence stays on this page and is never placed in a link.
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Frequently asked questions
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.
Does this create an official FSCA notice?
No. It can identify inputs and gaps for a notice and action plan, but the controlled final communication requires market-specific review and approval.