Blue Goat Cyber

Blue Goat Cyber is an international consulting firm specializing in cybersecurity for medical devices, serving manufacturers in North America, Europe, and the Asia-Pacific (APAC) region. We assist device companies in developing secure and resilient products by incorporating cybersecurity considerations at every phase of the development process. Our knowledge encompasses various global regulatory standards, such as FDA, EU MDR/IVDR, Health Canada, MHRA, TGA, and specific APAC regulations, helping our clients confidently comply with international market demands. Our specialties include secure product development, threat modeling, software bill of materials (SBOM) creation and management, penetration testing, vulnerability assessments, and cybersecurity risk management in accordance with ISO 14971, IEC 81001-5-1, IEC 62304, and AAMI TIR57. Blue Goat Cyber simplifies complex cybersecurity and regulatory requirements into clear and actionable plans that expedite submissions, enhance compliance, and mitigate risks. In addition to premarket support, we offer comprehensive lifecycle services such as postmarket surveillance, coordinated vulnerability disclosure, incident response planning, and remediation advice. By aligning cybersecurity practices across global regions, including the rapidly growing APAC markets, Blue Goat Cyber empowers manufacturers to improve patient safety, ensure operational continuity, and implement secure connected technologies globally.