Regulated evidence workspace
Medical device regulatory evidence workspace for SaMD and connected-device teams
VigilySys helps medical device teams connect requirements, safety risk, cybersecurity risk, privacy risk, usability engineering, verification, and submission readiness in one controlled evidence workspace.
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.