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VigilySys
VigilySys solutions for regulated evidence work
Choose the evidence workflow that matches your route-to-market pressure.
Evidence
Regulatory evidence workspace
Connect requirements, risks, usability, cybersecurity, privacy, verification, and readiness.
SaMDSaMD compliance software
Structure software-device evidence from intended use to submission readiness.
TraceabilityMedical device traceability software
Map requirements to risks, controls, verification, and evidence.
CybersecurityCybersecurity evidence
Connect SBOM, threat modeling, controls, and verification evidence.
UsabilityUsability engineering evidence
Connect user profiles, scenarios, use errors, hazards, and validation evidence.
ReadinessSubmission readiness
See evidence completeness across FDA, CE, and UKCA preparation.