2-minute assessment
How submission-ready is your cybersecurity package?
Seven questions mapped to the FDA premarket cybersecurity guidance. Get a score, gap list, and your fastest path to clearance.
Question 1 of 70% complete
Do you have a documented threat model traceable to your design inputs?
Close the gaps
Where to focus next.
Each readiness dimension maps to a dedicated service. Start with the lowest-scoring areas first.
Threat modeling for medical devices
Documented STRIDE-based threat model traceable to your design inputs.
Read Threat modeling for medical devicesFDA-compliant SBOM services
SPDX/CycloneDX SBOMs with continuous CVE and KEV mapping.
Read FDA-compliant SBOM servicesMedical device penetration testing
Independent exploit-driven testing across device, wireless, USB, and cloud paths.
Read Medical device penetration testingFDA premarket cybersecurity
Full SPDF + eSTAR-ready submission package aligned to current FDA guidance.
Read FDA premarket cybersecurityPostmarket cybersecurity program
Vulnerability monitoring, CVD, patch validation, and FDA reporting workflows.
Read Postmarket cybersecurity programCost-of-delay calculator
Quantify what every week of submission slip costs in revenue and runway.
Read Cost-of-delay calculator