Business profile

Categories

• Healthcare & Medical (primary)
• Software & IT

Services

• AI/ML Medical Device Security — AI/ML-specific threat modeling, adversarial robustness testing, and submission documentation for AI-enabled medical devices - aligned with FDA's PCCP framewor
• ANSI/AAMI SW96 + ISO 14971 alignment
• Adversarial ML testing (evasion, poisoning, model inversion, prompt injection)
• Blue Goat Cyber — Medical device cybersecurity specialists. Service-disabled veteran-owned firm helping MedTech manufacturers clear FDA premarket cybersecurity review with fixed-fee, retest-included engagements.
• Cloud + mobile + API pen testing (OWASP ASVS / MASVS) and IAM/tenancy review
• Cryptography and key management
• Developer training for medical teams
• End-to-end medical device system coverage
• Entire FDA Section 524B premarket cybersecurity package, owned end-to-end
• FDA 510(k) / De Novo / PMA cybersecurity submission
• GDPR Art. 30 / 32 / 35 readiness, DPIAs, and DPA templates
• GMLP + AAMI CR34971 alignment
• HIPAA Security Rule risk analysis and BA agreements
• HITRUST CSF e1 / i1 / r2 readiness for HDO procurement
• Justified methodology and assumptions
• MedTech Compliance Bundle — Bundled FDA cybersecurity, SOC 2 Type II, HIPAA, HITRUST, and GDPR program for MedTech innovators. One control set, five attestations, hospital- and EU-ready.
• Medical Device Threat Modeling — FDA-aligned threat modeling for medical devices. STRIDE, attack trees, trust boundaries, and risk traceability per AAMI TIR57 and SW96. Reviewer-ready evidence.
• Model lifecycle, monitoring, and drift controls
• PCCP authoring and FDA AI/ML transparency artifacts
• SBOM (app + container) with VEX, vulnerability mgmt plan, and patchability narrative
• SOC 2 Type II readiness and audit support
• SaMD Cybersecurity — Full-service premarket cybersecurity package for Software as a Medical Device (SaMD) - cloud-hosted clinical software, mobile diagnostic apps, web-based image
• Secure MedTech Product Design — Build a Secure Product Development Framework FDA accepts. SPDF design, documentation, and implementation aligned with Section 524B, AAMI SW96, IEC 81001-5-1.
• Secure boot and update strategy
• Security architecture and trust boundaries
• Single crosswalk - one set of controls, five attestations
• Threat model, secure design docs, architecture views, and labeling
• Threat-to-mitigation traceability

Service areas

• Scottsdale, AZ, United States

Public contacts

• Public email: info@bluegoatcyber.com
• Public phone: +1-844-939-4628
• instagram: https://www.instagram.com/bluegoatcyber/
• linkedin: https://www.linkedin.com/company/blue-goat-cyber
• linkedin: https://www.linkedin.com/in/christianespinosa
• mdcpodcast: https://mdcpodcast.com/
• twitter: https://twitter.com/bluegoatcyber
• youtube: https://www.youtube.com/@BlueGoatCyber

Declared AI capabilities

• Online booking — Detected from public website navigation or discovery metadata.
• Online support — Detected from public website navigation or discovery metadata.

Directory status

Registry verification: Not Registry Verified

Directory score: 100

Public source evidence

• Medical Device Cybersecurity for FDA Clearance
• Medical Device Threat Modeling | AAMI TIR57 / SW96
• AI/ML Medical Device Security | Medical Device Cybersecurity
• FDA + SOC 2 + HIPAA + HITRUST + GDPR Bundle
• SaMD Cybersecurity | Medical Device Cybersecurity
• GoatWatch: SBOM Management Tool for Medical Devices
• MedTech Cybersecurity Services & SBOM
• Medical Device SPDF Consulting | FDA-Aligned