Model-based assurance
From MVP to regulatory review-ready proof.
Model the system. Connect the evidence. Know what is ready. VigilySys helps medical device teams connect system context, assurance domains, verification, controlled outputs and human review in one governed Vigilance Map.
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Product views for route-to-market work
VigilySys connects requirements traceability, ISO 14971 risk controls, cybersecurity evidence, privacy and DPIA evidence, IEC 62366 usability evidence, and FDA CE UKCA readiness signals in one controlled evidence model.