250+ Submissions · Zero Rejections

Blue Goat Cyber — Medical Device Cybersecurity for FDA Clearance

Full-service medical device cybersecurity consulting: penetration testing, SBOMs, threat modeling, and eSTAR-ready documentation that lands 510(k), De Novo, and PMA submissions on the first pass. Aligned with the FDA February 2026 Final Premarket Cybersecurity Guidance — Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions.

SDVOSB firm founded in 2022. 250+ FDA submissions supported. 100% success rate. Fixed-fee engagements with unlimited retests until you clear.

Medical Device Cybersecurity Services

• FDA Premarket Cybersecurity Services — full SPDF documentation for 510(k), De Novo, PMA
• FDA Cybersecurity Deficiency Response — fast turnaround on FDA AI letters
• FDA Postmarket Cybersecurity Services — VDP, CVD, vulnerability monitoring
• Medical Device Penetration Testing
• Threat Modeling Services — STRIDE / AAMI TIR57
• FDA-Compliant SBOM Services — SPDX / CycloneDX with VEX
• Secure MedTech Product Design Consulting
• Legacy Medical Device Cybersecurity
• AI/ML Medical Device Security & PCCP
• HIPAA Penetration Testing
• Wireless Penetration Testing

Resources

• Blog — medical device cybersecurity articles
• Guides — in-depth playbooks
• Playbooks (free PDFs) — including the FDA 2026 Premarket Decoder
• Case Studies — anonymized engagement outcomes
• Testimonials from MedTech leaders
• The Med Device Cyber Podcast
• News
• FAQs
• Standards Glossary — IEC 62304, ISO 14971, AAMI TIR57, FDA 524B

Company

• About Blue Goat Cyber
• Leadership — Christian Espinosa, Founder & CEO
• Why Blue Goat Cyber
• Contact — info@bluegoatcyber.com

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