One platform across the whole lifecycle — from first design decision through to post-launch.
Every record connected — a document links to its training, its change history, its quality events. Nothing lives in a silo.
Controlled documents with check-out, e-sign approval and automatic change notes.
Auto-assigned when a document goes effective. Matrix and overdue tracking built in.
NC, CAPA, change requests, incidents — one configurable event engine.
Equipment, calibration and computerised system validation records.
Approved supplier list, risk matrix and re-evaluations that run themselves.
AI algorithm monitoring that raises quality events when performance drifts.
Requirements to validation with live traceability — MDR, IVDR and 510(k) ready.
Draft, review, summarise, search — a human quality professional is always the signatory of record.
Built on the frameworks your auditors already trust — not bolted on afterwards.
Sixteen years in medical device quality taught me one thing — the tools were built for auditors, not for the people doing the work. So we built the one we always wanted.
Set up your evaluation space in two minutes — seeded for your regulatory scope.
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