Accelerate FDA & Regulatory Approval with Full-Service Medical Device Cybersecurity
We handle 100% of your cybersecurity requirements — from penetration testing and SPDF development to SBOMs, risk analysis, and submission-ready documentation. Done for you. Done right.
Trusted by Leading MedTech Startups and Manufacturers Since 2014
MedTech Industry Compliance Standards We Follow
ISO 14971 • FDA Guidance • UL 2900 • AAMI TIR57 • NIST 800-115 • IEC 62304 • ISO 13485 • AAMI TIR97 • ISO 27001 • IEC 81001-5-1 • IEC 62443-4-1
Get FDA Approval and Protect Patients — Without the Cybersecurity Headaches
You’re building breakthrough medical technology to improve lives. But with FDA requirements, evolving cyber threats, and tight timelines, cybersecurity can feel overwhelming — and high stakes.
At Blue Goat Cyber, we make it simple.
We specialize in full-service cybersecurity for medical devices — so you can protect your patients, meet regulatory demands, and bring your device to market with confidence.
🔐 Our Cybersecurity Services — Tailored to Your Stage
✅ Premarket: Launch Secure, Submit Faster
Design Consulting: Build cybersecurity into your device from day one
Penetration Testing: Simulate real-world threats before they reach patients
SPDF, SBOMs, & Risk Documentation: 100% FDA-ready and aligned with AAMI TIR57, ISO 14971, IEC 62304
FDA Deficiency Support: Fix issues fast, with experts who’ve done it hundreds of times
🔄 Postmarket: Stay Secure After Approval
Continuous Compliance Management: Patching, monitoring, reporting — done for you
Legacy Device Protection: Secure existing devices without breaking functionality
⚠️ What’s at Stake If You Get Cybersecurity Wrong?
⏳ Delays that cost months of revenue
⚠️ Vulnerabilities that could harm patients
📄 Deficiencies that risk your entire submission
💔 Reputational damage that’s hard to undo
How We Help You Win
Book a Free Discovery Session
Get a tailored cybersecurity & compliance plan
Submit with confidence — protect patients, reputation, and market access
🔵 Start Your FDA Cybersecurity Journey Now
30 minutes with a medical device cybersecurity expert. No pressure. Just clarity and next steps.
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 Vulnerability & 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
Why We Exist
We protect lives by securing the medical devices that power modern healthcare.
By eliminating cybersecurity uncertainty, we help MedTech innovators bring life-saving technology to market — faster, safer, and fully FDA-compliant.
Vision
A future where every connected medical device is secure, trusted, and resilient — protecting patients, enabling innovation, and earning regulatory confidence.
Mission
We help medical device companies secure their products, achieve FDA cybersecurity compliance, and protect patient lives — with full-service testing, documentation, and expert guidance at every stage.
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.
