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
Scottsdale, Arizona, United States, North America
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
FDA Premarket Cybersecurity Services
End-to-end cybersecurity support for premarket submissions including threat modeling, SBOM creation, security documentation, testing, and secure design consulting.
Medical Device Cybersecurity Testing and RVT
Vulnerability assessments and penetration testing for devices, embedded systems, networks, cloud integrations, and firmware with remediation validation and reporting suitable for regulators.
Postmarket Cybersecurity Management
Ongoing monitoring, coordinated vulnerability disclosure, patch and update management, and incident response to maintain device security after market entry.
SBOM-as-a-Service and Software Composition Analysis
Generate and validate SBOMs and perform component analysis to identify third-party components and known vulnerabilities in standard formats.
Secure Product Design Consulting
Advisory services to embed security into product design and development, including boundary analysis, design inputs, and secure architecture reviews.
FDA Premarket Cybersecurity Services
End-to-end cybersecurity support for premarket submissions including threat modeling, SBOM creation, security documentation, testing, and secure design consulting.
Medical Device Cybersecurity Testing and RVT
Vulnerability assessments and penetration testing for devices, embedded systems, networks, cloud integrations, and firmware with remediation validation and reporting suitable for regulators.
Postmarket Cybersecurity Management
Ongoing monitoring, coordinated vulnerability disclosure, patch and update management, and incident response to maintain device security after market entry.
SBOM-as-a-Service and Software Composition Analysis
Generate and validate SBOMs and perform component analysis to identify third-party components and known vulnerabilities in standard formats.
Secure Product Design Consulting
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)