Blue Goat Cyber

Blue Goat Cyber is a global medical device cybersecurity consulting firm supporting manufacturers across North America, Europe, and the Asia-Pacific (APAC) region. We help device companies build secure, resilient products by integrating cybersecurity into every stage of the development lifecycle. Our expertise spans global regulatory frameworks—including FDA, EU MDR/IVDR, Health Canada, MHRA, TGA, and APAC-specific requirements—ensuring clients can confidently meet international market expectations.

We specialize in secure product development, threat modeling, SBOM creation and management, penetration testing, vulnerability assessments, and cybersecurity risk management aligned with ISO 14971, IEC 81001-5-1, IEC 62304, and AAMI TIR57. Blue Goat Cyber translates complex cybersecurity and regulatory requirements into clear, actionable strategies that accelerate submissions, strengthen compliance, and reduce risk.

Beyond premarket support, we provide full lifecycle services—including postmarket monitoring, coordinated vulnerability disclosure, incident response planning, and remediation guidance. By harmonizing cybersecurity practices across global regions, including rapidly expanding APAC markets, Blue Goat Cyber enables manufacturers to enhance patient safety, maintain operational continuity, and deploy secure connected technologies worldwide.