Blue Goat Cyber

Blue Goat Cyber

Professional Services

Scottsdale, Arizona 2,710 followers

We provide turnkey medical device cybersecurity services for FDA premarket submissions and postmarket management.

About us

Blue Goat Cyber was founded by Christian Espinosa, a cybersecurity expert with over a decade of experience in medical device security. After launching Alpine Security in 2014 and selling it in 2020, Christian’s personal health scare in 2022, involving a life-saving medical device, reignited his passion for securing devices that directly impact patient safety. This experience led to the founding of Blue Goat Cyber, focusing on medical device cybersecurity. At Blue Goat Cyber, we specialize in helping medical device manufacturers navigate complex FDA regulations and implement the highest standards of cybersecurity. Our services include comprehensive Software Bill of Materials (SBOM) management, threat modeling, Static Application Security Testing (SAST), and penetration testing. These services are designed to address every aspect of a device’s security lifecycle, ensuring it meets FDA expectations for premarket and postmarket submissions. We also offer vulnerability assessments, risk management reports, and continuous monitoring, providing manufacturers with the tools and insights needed to secure their devices from development through deployment. Our fixed-fee pricing model ensures transparency, with unlimited retests included until acceptable risk levels are achieved. Additionally, we guarantee FDA clearance for submissions related to cybersecurity—if any deficiencies arise, we resolve them at no additional cost. As a service-disabled veteran-owned business, we bring a unique perspective and dedication to medical device security. Blue Goat Cyber has a 100% success rate, with all submissions cleared on the first attempt. Our processes are fully aligned with the FDA’s latest eSTAR guidance, ensuring regulatory compliance and patient safety. Blue Goat Cyber is committed to making a meaningful impact in medical device cybersecurity, combining professional expertise with a personal commitment to safeguarding lives.

Industry
Professional Services
Company size
11-50 employees
Headquarters
Scottsdale, Arizona
Type
Privately Held
Founded
2022
Specialties
cybersecurity, penetration testing, medical device cybersecurity, web application penetration testing, FDA Compliance, 510(k) cybersecurity, FDA Cybersecurity , and FDA Premarket Cybersecurity

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Employees at Blue Goat Cyber

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