'/%3e%3cpath%20d='M16%2019h9.5L32%2041.8%2038.5%2019H48L35.4%2048h-6.8z'%20fill='%23f8fafc'/%3e%3ccircle%20cx='48'%20cy='16'%20r='4.5'%20fill='url(%23accent)'/%3e%3c/svg%3e)
Model the device context
Capture software scope, connectivity, users, data flows, cloud services, suppliers, and target route.
FDA cybersecurity readiness
Turn cybersecurity work into traceable premarket evidence
Connected devices need more than a threat model. Teams need a defensible chain from device context to risk, control, verification, SBOM, update planning, and residual-risk rationale.
Build the cyber evidence map
Link threats, vulnerabilities, controls, SBOM items, verification, and update process evidence.
Review gaps before submission pressure
Show missing controls, weak traces, incomplete SBOM rationale, and owner-ready review tasks.
What VigilySys helps produce
- Cyber risk register linked to device assets and intended use.
- Security controls linked to requirements, verification, and residual-risk decisions.
- SBOM and supplier-risk evidence connected to lifecycle monitoring.
- Readiness status for FDA cybersecurity evidence discussions.
The useful output is a reviewer-followable evidence chain, not a folder of disconnected security documents.