top of page
Don’t Let Cybersecurity Stall Your FDA Clearance
Most AI/ML and MedTech teams face the same roadblock: cybersecurity documentation.
Instead of scrambling with fragmented spreadsheets and last-minute consultants, Try out our Cybersecurity Document Generator
Whether you’re preparing a 510(k), De Novo, or PMA, or already received deficiency letters from the FDA, the expectations are clear:
-
Threat modeling (STRIDE) & risk assessments
-
SBOM with vulnerability traceability (KEV/NVD)
-
Security controls & testing evidence
-
Lifecycle monitoring & metrics
-
11 cybersecurity docs mapped to FDA’s 2025 guidance
-
Integrate with Jira, GitHub, CI/CD for living compliance
-
link risks → controls → tests → evidence
-
Build once, stay compliant across the device lifecycle
Get the API Key
bottom of page