FDA cybersecurity compliance experts for medical devices
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.
What our compliance experts do
Premarket cybersecurity
SPDF, threat model, SBOM, risk assessment and eSTAR-ready documentation for 510(k), De Novo and PMA submissions.
Medical device penetration testing
Mostly manual, expert-led testing of device, wireless, mobile and cloud surfaces, with a signed summary of tester independence, scope, methods and findings.
FDA deficiency response
A free gap analysis within 48 hours of your deficiency letter, then the evidence and responses the reviewer asked for.
Postmarket cybersecurity
Daily vulnerability matching, triage by a named engineer, SBOM refresh, annual testing and the reporting Section 524B expects.
Threat modeling
STRIDE-based threat models tied to your ISO 14971 risk file and traced to your testing.
SBOM services
Machine-readable SBOMs with VEX statements, kept current after clearance.
Who you work with
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 cybersecurity deficiencies after our submission, we resolve them at no additional cost.
How to choose compliance experts
- A track record of FDA submissions, not only enterprise IT audits.
- Testers who are independent from your development team.
- Senior engineers doing the work, with one named lead you can reach.
- Work mapped to ISO 14971, AAMI TIR57, AAMI SW96 and IEC 81001-5-1.
- A fixed fee agreed before work starts.
- Support after the FDA responds, not only up to submission.
More detail in our guide to choosing a medical device cybersecurity company and our cost guide.
Get a fixed-fee quote from FDA cybersecurity compliance experts.
30-minute call with a senior engineer. No cost, no commitment.