
01 · Regulated workflow engine
Clearance
A workflow engine for the FDA 510(k) premarket process.
A device moves from registration through RTA screening, review and risk assessment to a signed decision, with every step gated by role and timed against the 90-day clock the FDA reports on. Every number is computed from events and every decision is accountable.
- Year
- 2026
- Type
- Web app
- Status
- Live demo
Event-sourced and append-only
Device state is a fold over an event log. A database trigger rejects UPDATE and DELETE, so the audit trail can't be rewritten, not even by a bug.
The workflow is data, not code
One transition table drives graph validation, the generated diagram and the exact actions the UI offers, with a reason shown for every blocked one.
Part 11-style signatures
Decisions are signed against the exact record version the signer saw. Any past version replays on the server and can be shared as a link.
Document analysis that cites
Uploaded PDFs are analysed by a background worker. Every finding quotes its page, quotes are checked against that page, and accuracy is held to a baseline by a CI quality gate.
Built with
- Clojure
- PostgreSQL
- Malli
- reitit
- PDFBox
- Vue 3
- TypeScript
- Playwright
