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.
Full-service: we produce the full cybersecurity documentation set 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 PremarketMedical device SBOM services with source, build, and binary evidence reconciliation, component vulnerability assessment, and support-status verification. SPDX by default; fixed fee after scoping.
Explore service PremarketMedical device penetration testing services across agreed hardware, firmware, wireless, app, and cloud attack paths. Threat-traced Test Plan, Test Cases, and Test Report for FDA submission documentation.
Explore serviceFree 30-minute strategy session with a senior MedTech cybersecurity expert. No cost, no commitment.
