One senior US-based team for the whole FDA cybersecurity scope: design, submission, testing, deficiency response, and postmarket. Built to Section 524B and the February 3, 2026 premarket guidance.
Direct answer
FDA cybersecurity is the set of design, documentation, and testing evidence a medical device manufacturer uses to address Section 524B of the FD&C Act and the FDA's February 3, 2026 premarket cybersecurity guidance. It spans the full product lifecycle: a Secure Product Development Framework and threat model during design, an SBOM, optional VEX statements, and recommended penetration test evidence at submission, and vulnerability monitoring, coordinated disclosure, and patch delivery after clearance. Blue Goat Cyber owns that scope end to end for 510(k), De Novo, PMA, PDP, and HDE programs.
Four entry points, depending on where your device is today. Every one starts with a free 30-minute call with a senior engineer and a mutual NDA.
You are not sure what the FDA will ask for.
A senior engineer reviews your architecture and existing documentation against Section 524B and the February 2026 guidance, then returns a point-by-point gap list with the artifact that closes each one.
Run the readiness checkYou are still building and want to avoid rework.
We embed alongside your engineering team, set the security architecture and control selection, and build the SPDF into your existing QMSR or ISO 13485 processes before the code is frozen.
Secure product designYour device is nearly done and the submission is next.
We deliver every cybersecurity artifact the reviewer expects, formatted for the current eSTAR template and traceable back to the threat model and risk assessment.
Premarket cybersecurityYou already submitted and got an AI or hold letter.
Point-by-point reviewer-ready responses inside your 180-day clock, with each response mapped to the reviewer comment and the specific Section 524B clause it answers.
Deficiency responseEach phase links to the service page that owns the work. Most manufacturers engage us for two or three of these at once.
The cybersecurity evidence a reviewer looks for, and whether it belongs to the premarket submission, the postmarket program, or both.
| Artifact | What it contains | Phase |
|---|---|---|
| Security architecture views | Global system, multi-patient harm, use case, and updateability views | Premarket |
| Threat model | STRIDE analysis with assets, threat actors, attack paths, and safety impact | Premarket |
| Security risk assessment | Traceability from vulnerability to control to residual risk under ISO 14971 | Premarket |
| Cybersecurity controls | Controls addressing the FDA risk control categories, with verification evidence | Premarket |
| SBOM plus VEX | Machine-readable SBOM, support levels, end-of-support dates, CVE applicability | Both |
| Testing evidence | Penetration testing, fuzz testing, vulnerability scanning, and SCA reports | Premarket |
| Cybersecurity management plan | Monitoring sources, response timelines, patch delivery, and disclosure policy | Both |
| Cybersecurity labeling | Customer security guide, SBOM disclosure, and end-of-support communication | Both |
| Metrics and monitoring | Measures that show the controls stay effective after clearance | Postmarket |
The full 18-artifact breakdown, with what each one has to prove, lives on the FDA premarket cybersecurity service page. For the underlying regulation, see our guide to FDA cybersecurity guidance and Section 524B requirements explained.
Every engagement is a fixed fee, quoted in writing within 24 hours of the discovery call. No hourly billing and no surprise change orders.
Software-only device
Fixed fee after scoping
SaMD, cloud, and mobile scope. Typically 6 to 8 weeks to a submission-ready binder.
Connected device
Fixed fee after scoping
Firmware, wireless, and cloud attack surfaces. Typically 8 to 10 weeks.
Complex or PMA
Fixed fee after scoping
Multi-component systems, AI/ML, or PMA-class traceability depth. Scoped per program.
Postmarket is priced separately as an annual engagement. Deficiency response is scoped against the letter.
Check whether Section 524B applies to your device, then score your submission readiness against the current guidance.
Free 30-minute call, mutual NDA signed first, and a fixed-fee quote within 24 hours. We will tell you straight if you do not need us.
