Full-Service MedTech Cybersecurity
Don’t Let Cybersecurity Risks Delay Your Medical Device Premarket Approval
We identify vulnerabilities, ensure compliance, and guide you through every step of the premarket submission process with confidence.
Serving the MedTech Industry Since 2014
Medical Device Cybersecurity Premarket Submission Services
We handle all the cybersecurity requirements for your medical device’s premarket submission, including thorough documentation, testing, and regulatory compliance.
Medical Device Cybersecurity Penetration Testing Services
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.
Medical Device Cybersecurity Postmarket Management Services
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.
Recent Clients
Streamlined Premarket Cybersecurity Solutions to Accelerate Approvals and Protect Patients
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.
Our Services
Premarket Cybersecurity: Build a Solid Foundation for Success
We help you secure your devices early, so you can achieve faster regulatory approvals and avoid delays:
- Design Consulting: Build cybersecurity into your devices from day one with expert guidance during the design and development phases.
- Regulatory Submission Packages: Simplify FDA and EU MDR/IVDR approvals with comprehensive documentation and tailored support.
- Penetration Testing: Identify and address vulnerabilities before your devices reach the market.
- FDA Deficiency Response: Quickly resolve cybersecurity deficiencies and keep your regulatory timeline on track.
Postmarket Cybersecurity: Maintain Safety and Compliance
We protect your devices after launch to ensure safety, reliability, and compliance:
- Ongoing Management: Monitor for emerging threats, manage patches, and maintain regulatory compliance.
- Legacy Device Protection: Safeguard older devices from vulnerabilities without compromising performance.
Your Path to Success
- Schedule a Discovery Session to discuss your challenges and goals.
- Get a tailored cybersecurity plan for your devices, whether in development or on the market.
- Protect your devices, patients, and reputation while achieving regulatory success.
What’s at Stake?
Without robust cybersecurity, your devices face real risks:
- Regulatory delays.
- Patient safety incidents.
- Damage to your reputation.
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.
Take the First Step Today
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.
Purpose
We protect lives by securing medical devices against evolving cyber threats.
Vision
To create a future where every medical device is trusted to protect and enhance lives without compromise.
Mission
We deliver cybersecurity services that protect medical devices, ensure regulatory compliance, and safeguard patients in a rapidly changing digital world.
Core Beliefs
Patient Safety Comes First
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.
Security Enables Innovation
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.
Trust Is Earned Through Action
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.
Proactive Solutions Prevent Future Threats
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.
Compliance Is the Starting Point, Not the Goal
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.
Collaboration Drives Success
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.
The Stakes Are Too High for Anything Less Than Excellence
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.
Testimonials
What they say about us.
We ensure you have a great experience with us.
