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Use cases
Route-to-market evidence workflows for medical device teams
Each use case shows how VigilySys turns product context, risk work, usability evidence, verification, and submission readiness into a connected workspace.
FDA
Cybersecurity readiness
Prepare premarket cyber evidence, SBOM rationale, update planning, and control traceability.
CE / UKCATechnical file readiness
Connect software lifecycle, architecture, usability, risk controls, and verification evidence.
CommercialHospital buyer due diligence
Share credible cybersecurity, privacy, supplier, and traceability evidence with procurement teams.
RiskIntegrated risk traceability
Manage safety, security, privacy, usability, and verification links from one device-level model.