End-to-end premarket cybersecurity package, eSTAR-ready
510(k), De Novo, or PMA goes to FDA
When the package goes to FDA, every cybersecurity artifact is connected: SPDF, threat model, SBOM, pen test report, and the Section 524B narrative trace cleanly back to your design controls and risk file. We deliver the full evidence set in the format reviewers expect - so the cybersecurity portion of your submission isn't what holds it up.
How we move you through fda submission
- Complete Section 524B documentation packaged for eSTAR
- SPDF, threat model, SBOM, and pen test report cross-traceable
- Submission narrative written to the FDA Feb 2026 guidance
- 275+ FDA submissions supported, no cybersecurity-related rejections to date
Services that fit this stage
Full-Service FDA Premarket Cybersecurity
Full-service, end-to-end: we deliver 100% of the artifacts FDA reviewers expect for 510(k), De Novo, PMA, PDP, and HDE submissions under §524B, plus IDE applications under 21 CFR 812 and the FDA's February 3, 2026 premarket guidance - traceable, complete, and current.
Explore service PremarketFDA-Compliant SBOM Services
Machine- and human-readable SBOMs with NTIA minimum elements (superseded by CISA's 2026 Minimum Elements for an SBOM, published July 29, 2026), vulnerability mapping, and end-of-support tracking - built for FDA review.
Explore service PremarketMedical Device Penetration Testing
Hardware, firmware, mobile, and cloud - tested by operators with both red-team and medical-device experience. Reports built for FDA reviewers.
Explore serviceReady to take on fda submission?
Free 30-minute strategy session with a senior MedTech cybersecurity expert. No cost, no commitment.