Cybersecurity Services
The cybersecurity firm Christian founded to get devices cleared and keep them safe.
Christian's cybersecurity work runs through Blue Goat Cyber, a medical-device-only firm covering premarket FDA submissions, penetration testing, postmarket monitoring, and go-to-market compliance (SOC 2, HIPAA, HITRUST, GDPR, EU CRA). Fixed-fee pricing, clearance-guaranteed engagements.
What Blue Goat delivers
One accountable partner across the entire device lifecycle.
37+ services grouped into four programs. Engage one piece or the full package.
FDA submissions & secure design
-
Full-Service FDA Premarket Cybersecurity
We own 100% of SPDF, SBOMs, threat modeling, pen testing, and eSTAR documentation for 510(k), De Novo, and PMA.
Explore ↗ -
Medical Device Threat Modeling
FDA-aligned threat models that identify risks early and speed approvals. STRIDE, attack trees, and clinical risk linkage.
Explore ↗ -
FDA Deficiency Response
Got an FDA hold or AI letter? We close cybersecurity deficiencies fast with senior engineers and ready-to-submit responses.
Explore ↗ -
AI/ML Medical Device Security
Defend AI/ML SaMD against adversarial attacks and meet FDA's PCCP, GMLP, and 2025 AI-enabled device guidance.
Explore ↗
Find what attackers will find, first
-
Medical Device Penetration Testing
FDA-compliant device, firmware, app, and cloud testing. Black, gray, and white box across the full attack surface.
Explore ↗ -
BLE, Wi-Fi & RF Testing
Wireless interface testing for BLE, Wi-Fi, Zigbee, NFC, and proprietary RF on connected devices.
Explore ↗ -
Web, API & Mobile App Pen Testing
Front-end, back-end, REST and GraphQL APIs, plus iOS and Android coverage in one engagement.
Explore ↗
Clear procurement, hospital security, and EU launch
-
MedTech Compliance Bundle
One program covering FDA Clearance, SOC 2, HIPAA, HITRUST, and GDPR, run in parallel for hospital-ready and EU-ready launch.
Explore ↗ -
SOC 2 Type II for MedTech
Readiness, control build, and audit support so HDO procurement stops blocking your contracts.
Explore ↗ -
EU CRA for Medical Devices
Cyber Resilience Act readiness: essential cybersecurity requirements, vulnerability handling, and CE-mark conformity before December 11, 2027.
Explore ↗
Stay cleared, stay safe, after launch
-
FDA Postmarket Cybersecurity
Continuous compliance, monitoring, and vulnerability response aligned to FDA Section 524B postmarket plans.
Explore ↗ -
GoatWatch: SBOM Monitoring & VEX
Daily CVE matching, device-context triage, and VEX-ready evidence aligned to FDA Section 524B, without the noise.
Explore ↗ -
Legacy Device Protection
Reduce risk on fielded devices, no redesign, no new submission, no downtime.
Explore ↗
See the full catalogue of 37+ services on the Blue Goat Cyber site.
Browse all services ↗The lifecycle
Premarket through postmarket, mapped.
Track record
250+ FDA submissions. Zero cybersecurity rejections.
Blue Goat Cyber backs every submission with a 100% FDA clearance guarantee: if FDA raises cybersecurity deficiencies, the team resolves them at no additional cost.
- 250+
- FDA submissions supported
- 2–4 wk
- To submission-ready
- 0
- Cyber-driven rejections
- 100%
- Clearance guarantee
- FDA 2026 Guidance
- AAMI SW96
- ISO 13485
- ISO 14971
- Penetration Testing
- SBOMs
- Threat Modeling
Get in touch
Talk to the team at Blue Goat Cyber.
Email info@bluegoatcyber.com or call +1 (844) 939-4628. Response within one business day. Service-disabled veteran-owned. Clients across North America, Europe, the Middle East, and Asia-Pacific.