Blue Goat Cyber
Consultancy focused on medical device cybersecurity and regulatory compliance across the product lifecycle. Services include premarket submission support, vulnerability testing and remediation validation, SBOM generation and management, threat modeling, secure product development guidance, and postmarket vulnerability management.
Industries
Nr. of Employees
small (1-50)
Blue Goat Cyber
1776 North Scottsdale Road, Unit 666, Scottsdale, AZ 85257 (mailing address and payment remittance PO Box in St. Louis, MO shown on contact page)
Products
Medical Device Cybersecurity Premarket Submission Services
Manages all cybersecurity requirements for medical device premarket submissions, including documentation, testing, and regulatory compliance.
Medical Device Vulnerability & Penetration Testing Services
Provides FDA-compliant vulnerability assessments and penetration testing tailored to medical devices for regulatory submissions.
Medical Device Cybersecurity Postmarket Management Services
Delivers ongoing cybersecurity support post-FDA approval, including SBOM monitoring, threat detection, patch management, and legacy device security.
Medical Device Cybersecurity Premarket Submission Services
Manages all cybersecurity requirements for medical device premarket submissions, including documentation, testing, and regulatory compliance.
Medical Device Vulnerability & Penetration Testing Services
Provides FDA-compliant vulnerability assessments and penetration testing tailored to medical devices for regulatory submissions.
Medical Device Cybersecurity Postmarket Management Services
Delivers ongoing cybersecurity support post-FDA approval, including SBOM monitoring, threat detection, patch management, and legacy device security.
Services
End-to-end cybersecurity support for premarket submissions including threat modeling, SBOM creation, security documentation, testing, and secure design consulting.
Vulnerability assessments and penetration testing for devices, embedded systems, networks, cloud integrations, and firmware with remediation validation and reporting suitable for regulators.
Ongoing monitoring, coordinated vulnerability disclosure, patch and update management, and incident response to maintain device security after market entry.
Generate and validate SBOMs and perform component analysis to identify third-party components and known vulnerabilities in standard formats.
Advisory services to embed security into product design and development, including boundary analysis, design inputs, and secure architecture reviews.
End-to-end cybersecurity support for premarket submissions including threat modeling, SBOM creation, security documentation, testing, and secure design consulting.
Vulnerability assessments and penetration testing for devices, embedded systems, networks, cloud integrations, and firmware with remediation validation and reporting suitable for regulators.
Ongoing monitoring, coordinated vulnerability disclosure, patch and update management, and incident response to maintain device security after market entry.
Generate and validate SBOMs and perform component analysis to identify third-party components and known vulnerabilities in standard formats.
Advisory services to embed security into product design and development, including boundary analysis, design inputs, and secure architecture reviews.
Expertise Areas
- Medical device cybersecurity
- Regulatory compliance for premarket and postmarket submissions
- Penetration testing and red teaming for medical devices
- Software supply chain security and SBOM management
Key Technologies
- Software Bill of Materials (SBOM) — SPDX and CycloneDX
- Software composition analysis (SCA)
- Static application security testing (SAST)
- Dynamic application security testing (DAST)
News & Updates
Presentation on cybersecurity expectations from FDA software reviewers and a blueprint for integrating security into design and submissions.
Sponsored LSI Asia 2025; CTO moderated a panel on common cybersecurity mistakes that stall MedTech market momentum.
Founder featured speaker on integrating security across the device lifecycle to align with global standards and accelerate market access.
Release of the 21st episode of the podcast series providing practical guidance on medical device cybersecurity, regulatory expectations, and postmarket risk management.
Commentary and service summary aligned to finalized FDA medical device cybersecurity guidance.
Educational article explaining man-in-the-middle techniques, impacts, and mitigation strategies relevant to networked device security.
Presentation on cybersecurity expectations from FDA software reviewers and a blueprint for integrating security into design and submissions.
Sponsored LSI Asia 2025; CTO moderated a panel on common cybersecurity mistakes that stall MedTech market momentum.
Founder featured speaker on integrating security across the device lifecycle to align with global standards and accelerate market access.
Release of the 21st episode of the podcast series providing practical guidance on medical device cybersecurity, regulatory expectations, and postmarket risk management.
Commentary and service summary aligned to finalized FDA medical device cybersecurity guidance.
Educational article explaining man-in-the-middle techniques, impacts, and mitigation strategies relevant to networked device security.