We handle all the cybersecurity requirements for your medical device’s premarket submission, including thorough documentation, testing, and regulatory compliance.
We handle all third-party vulnerability assessments and penetration testing requirements for your medical device's FDA and EU MDR submissions, ensuring full compliance with both regulatory standards.
We specialize in delivering comprehensive postmarket cybersecurity support for medical device manufacturers, ensuring ongoing compliance with FDA and EU MDR requirements while maintaining device security and effectiveness throughout its lifecycle.
You’re a medical device manufacturer driven to create innovative products that improve lives. But with evolving cyber threats and complex regulatory requirements, the path to success can feel overwhelming. At Blue Goat Cyber, we understand what’s at stake—your reputation, your patients’ safety, and your ability to meet critical deadlines.
We specialize in tailored cybersecurity solutions that protect your devices and help you confidently navigate every stage of the product lifecycle. Whether you’re designing a new device or managing postmarket compliance, we’ll guide you every step of the way.
We help you secure your devices early, so you can achieve faster regulatory approvals and avoid delays:
We protect your devices after launch to ensure safety, reliability, and compliance:
Without robust cybersecurity, your devices face real risks:
With Blue Goat Cyber by your side, you’ll feel confident knowing your devices are secure, your patients are protected, and your company is positioned for long-term success.
Schedule your complimentary Discovery Session to learn how we can help protect your devices and streamline your path to regulatory approval.
Partner with Blue Goat Cyber—Securing the Future of Healthcare Innovation.
We protect lives by securing medical devices against evolving cyber threats.
To create a future where every medical device is trusted to protect and enhance lives without compromise.
We deliver cybersecurity services that protect medical devices, ensure regulatory compliance, and safeguard patients in a rapidly changing digital world.
We believe every patient deserves secure, reliable medical devices designed to protect lives without compromise. Our top priority is safeguarding the people who depend on your devices.
We believe cybersecurity is the foundation for advancing healthcare innovation. By addressing risks early, we empower manufacturers to deliver groundbreaking, life-saving solutions with confidence.
We believe trust is built by delivering solutions that meet the highest standards of security and compliance. Our tailored approach ensures your devices are not only compliant but also truly secure.
We believe proactive measures are the key to preventing costly vulnerabilities and ensuring long-term device security. We work ahead of emerging threats, so you can stay ahead of risk.
We believe meeting regulatory requirements is just the beginning. True success means creating secure devices that inspire trust and protect patients in a rapidly evolving landscape.
We believe in working side-by-side with manufacturers to solve challenges and build customized solutions. Your success is our mission, and collaboration is the cornerstone of everything we do.
We believe that lives depend on what we do, and we are committed to delivering exceptional cybersecurity solutions every time. You can rely on us to uphold the highest standards of quality and care.
We ensure you have a great experience with us.