Senior, US-based engineers who have supported more than 275 device submissions. We help device makers meet Section 524B and the FDA's 2026 premarket cybersecurity guidance.
Short answer
FDA cybersecurity compliance experts help medical device makers produce the security evidence the FDA expects under Section 524B: a secure development framework, threat model, SBOM, risk assessment, penetration testing and a postmarket plan. Good experts know how FDA reviewers read a submission, test independently, and stay with you if the FDA sends questions.
SPDF, threat model, SBOM, risk assessment and eSTAR-ready documentation for 510(k), De Novo, and PMA submissions.
Mostly manual, expert-led testing of device, wireless, mobile and cloud surfaces, with a signed summary of tester independence, scope, methods and findings.
A free gap analysis within 48 hours of your deficiency letter, then the evidence and responses the reviewer asked for.
Daily vulnerability matching, triage by a named engineer, SBOM refresh, annual testing and the reporting Section 524B expects.
STRIDE-based threat models tied to your ISO 14971 risk file and traced to your testing.
Machine-readable SBOMs with VEX statements, kept current after clearance.
Every engagement is led by a senior engineer, and most of our testing is done by hand. We use automated and AI-driven tools to speed things up, but experienced testers find the issues that matter. Our founder, Christian Espinosa wrote a book on medical device cybersecurity.
Meet the team, learn more on our About page, or see our team in the media.
If the FDA raises a cybersecurity question, we answer it at no extra cost until the cybersecurity portion is closed.
More detail in our guide to choosing a medical device cybersecurity company and our cost guide.
30-minute call with a senior engineer. No cost, no commitment.
