Products
Control Your Global Safety Signals.
Managing adverse events across 50 countries? Enter a complaint once. **Global Vigilance Hub** auto-generates the specific forms for FDA (eMDR), EU (MIR), and MFDS, ensuring you never miss a deadline.
Reportability Logic
Built-in decision trees guide your staff through the "Do we report this?" maze for each country's specific regulation.
Direct Submission
Don't just generate the PDF. Submit it directly to the FDA ESG or EUDAMED via our certified gateway.
Recall Command
Trigger a field safety action? Coordinate the retrieval of devices across your global supply chain from a single dashboard.
FAQ
Q. 蹂닿퀬 ?щ? 寃곗젙?€ ?쒖뒪?쒖씠 ?뚯븘???댁＜?섏슂?
A. The system guides you through a Decision Tree, but the final "Report/No Report" decision requires human sign-off.
Q. ?앹빟泥?蹂닿퀬???먮룞?쇰줈 ?섎굹??
A. Yes, generates files compatible with the MFDS electronic reporting portal.
Q. 留덉빟瑜????섏빟??蹂닿퀬???섎굹??
A. This system is for Medical Devices only. Please contact us for Pharma modules.