FDA cybersecurity
FDA cybersecurity readiness for startup teams
For a connected software-enabled device, cybersecurity is not an appendix to write at the end. Teams need evidence that risks were identified, controls were selected, residual risk was considered, and the device can be updated and monitored throughout its lifecycle.
What to prepare early
- Device profile: software scope, connectivity, cloud services, data flows, users, and deployment environment.
- Threat model and cybersecurity risk analysis linked to safety, privacy, and intended use.
- Security controls with design rationale, verification evidence, and residual risk decisions.
- SBOM covering commercial, open-source, and off-the-shelf software components.
- Security update, vulnerability monitoring, coordinated disclosure, and post-market response process.
VigilySys helps teams draft risk analysis, mitigation requirements, and traceability-gap findings so owners can
review evidence faster and keep accountability clear.
Common startup gap
Many teams can describe the product architecture but cannot show the chain from threat to control to verification to submission artifact. That traceability is what turns engineering work into evidence.