Run ISO 13485 design controls, CAPA, post-market surveillance and HIPAA/GDPR privacy from one workspace — without rebuilding evidence for every audit.
Link requirements, risks, V&V and design reviews to a single device record with version-controlled evidence.
Triage complaints, open CAPAs, run root-cause and effectiveness checks with full timestamped trail.
Capture adverse events, periodic safety updates and trending — exportable for notified bodies.
Onboard, score and re-qualify suppliers with audit evidence tied to each lot.
We replaced four tools and a SharePoint maze with one platform. Our last MDR surveillance audit closed with zero major findings.
— Head of Quality, Class IIb device manufacturer (EU)
Share your scope, team size and certification deadline — we'll come back with a tailored implementation plan within one business day.