Blue Goat Cyber

Security testing of APIs including documentation review, traffic interception, authentication and authorization probing, and fuzz testing.

Web application security testing of authentication, session management, business logic, and API integrations following OWASP guidance.

Penetration testing for HIPAA compliance focusing on technical safeguards for organizations handling ePHI.

Prepares threat models using STRIDE and attack trees, linking threats to patient safety and mapping security controls to regulatory requirements.

Rapid gap analysis and remediation planning for FDA-identified cybersecurity deficiencies, including updated technical documentation and submission support.

Continuous SBOM/CVE monitoring, incident response, and postmarket compliance reporting to meet FDA postmarket requirements.

SBOM generation, validation, CVE mapping, and regulatory documentation for submissions and postmarket monitoring.

GDPR compliance for medical devices including data mapping, DPIAs, technical and contractual controls, and MDR/IVDR integration.

Integrated program running FDA cybersecurity, SOC 2 Type II, HIPAA, HITRUST, and GDPR compliance in parallel, providing a single evidence vault for all frameworks.

SOC 2 Type II compliance program tailored for the MedTech sector with policy development, audit coordination, and regulatory evidence management.

Preparation and management of HITRUST certification, mapped to FDA, HIPAA, SOC 2, and GDPR frameworks for MedTech companies.

Adversarial testing, model robust evaluation, and lifecycle documentation for AI/ML-enabled or clinical-function medical devices.

Risk mitigation and compliance strategies for legacy medical devices through compensating controls, network isolation, and postmarket documentation.