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
- 250+ submissions cleared, zero rejections
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, and PMA submissions - traceable, complete, and aligned with current 524B guidance.
Explore service PremarketFDA-Compliant SBOM Services
Machine- and human-readable SBOMs with NTIA minimum elements, vulnerability mapping, and end-of-support tracking - built for FDA review.
Explore service PremarketPen Testing Methodology
A documented, repeatable testing methodology aligned with the FDA's 2026 premarket guidance, ANSI/AAMI SW96, ISO 14971, IEC 62443-4-1, and NIST 800-115 - designed to minimize risk to live systems and produce evidence that maps cleanly into your ISO 13485 quality records.
Explore serviceReady to take on fda submission?
Free 30-minute strategy session with a senior MedTech cybersecurity expert. No cost, no commitment.