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

Health Care
Medical Device
Medical
Medical Equipment Manufacturing

Nr. of Employees

small (1-50)

Blue Goat Cyber


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.

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
  • Show More (8)

Key Technologies

  • Software Bill of Materials (SBOM) — SPDX and CycloneDX
  • Software composition analysis (SCA)
  • Static application security testing (SAST)
  • Dynamic application security testing (DAST)
  • Show More (8)

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.

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