An AI-powered draft generator for EU MDR Periodic Safety Update Reports. Article 86 structure, your PMS data, your tone — assembled in minutes, not man-days.
Every QA/RA manager who has drafted a PSUR knows the pattern. You block out two or three days. You open the incident register, the complaint log, the PMCF findings, and the previous report. Then you spend the first six hours just structuring the document.
By day two you are copy-pasting between systems, reformatting tables, and manually cross-referencing UDI-DIs. The actual safety assessment — the thinking work — gets squeezed into the last afternoon because the mechanics ate the schedule.
Three steps from raw data to draft report.
Upload or paste incident reports, complaint logs, PMCF findings, and FSCA records. The tool reads structured and semi-structured inputs.
Benefit-risk analysis, trend summaries, aggregation tables, and narrative sections — all generated against the Article 86 template.
Edit in the browser, export to PDF or DOCX, and route through your QMS for PRRC sign-off before submission to the notified body.
Built-in MHRA alignment, MDR Article 86 structure, and version control so your technical file stays audit-ready.
While the draft generator is in development, we already ship a free Article 86 outline generator. Enter your device class and reporting period and get a conformant structure in seconds.
The live outline generator — free, no signup, shipping now.
Three tiers when the full generator ships. Early access reserved at a fixed discount.
A free Article 86 outline generator and this page. No AI pipeline. No document generator. We are testing whether QA/RA managers will pay for automated PSUR drafting before we build the full product. If you reserve a spot, you help shape what gets built — and you lock in early-access pricing when we ship.
Join the waitlist for the PSUR Draft Generator. Early access subscribers get 50 percent off for the first six months.
Request early access