PSUR Draft Generator: concept
A concept for assisting with periodic safety update report drafting. The full AI draft generator has not been built.
The problem
Preparing a periodic safety report can involve assembling source material from several systems. This concept explores assistance with that preparation; it does not establish a measured time saving.
The proposed workflow would still need evidence review and a responsible person to approve the final document.
How the concept could work
Four proposed steps from source material to a reviewed draft.
Connect your data
Upload or paste incident reports, complaint logs, PMCF findings, and FSCA records. The concept would accept source material for draft preparation. Input handling has not been implemented.
AI drafts every section
Benefit-risk analysis, trend summaries, aggregation tables, and narrative sections, proposed against a report outline; these capabilities have not been built.
Review, approve, submit
Proposed editing and export capabilities would need to be built and tested. Review and sign-off requirements must be agreed before use. Original plan: edit in the browser, export to PDF or DOCX, and route through your QMS for PRRC sign-off before submission to the notified body.
Review requirements
Proposed structure and version control would need specialist review.
The free tool, today
The full draft generator has not been built; separately, we already ship a free Article 86 outline generator. Enter your device class and reporting period and get a draft structure for review in seconds.
The live outline generator: free, no signup, shipping now.
What exists today
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. You can register interest to discuss requirements. There is no confirmed launch date or commercial offer.
Discuss the PSUR concept
Tell us what report preparation involves in your organisation. The full generator is unbuilt; the free outline tool is separate.
Register interest