Worried About FDA Cybersecurity Requirements? We Handle It All — So You Don’t Have To.
We manage 100% of your FDA cybersecurity submission — including SPDF, SBOMs, threat modeling, penetration testing, and all documentation — for 510(k), PMA, and De Novo approvals.
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
FDA Cybersecurity Requirements Just Got Tougher — We’ve Got You Covered.
The FDA’s latest cybersecurity guidance introduced a wave of new technical requirements — and most medical device teams are scrambling to keep up. Whether you’re submitting for the first time or responding to FDA deficiencies, trying to piece together SBOMs, threat models, and documentation on your own can be overwhelming, risky, and expensive.
The Stakes Are Real — and Measurable
💸 Millions in Lost Revenue
A delayed submission can push product launches back by 3–6 months. For a $20M/year device, that’s $1.5M+ in lost revenue — not including sunk costs or investor pressure.
📄 Rejections, Deficiencies, and Rework
Incomplete or incorrect documentation is one of the most common reasons for FDA cybersecurity feedback — leading to costly rework, time loss, and increased scrutiny on future submissions.
⚠️ Patient Safety and Brand Damage
Cybersecurity vulnerabilities in your device can lead to recalls, safety alerts, or even patient harm — eroding trust and opening the door to liability.
✅ At Blue Goat Cyber, We Help You Avoid All of This
We manage every detail — from SPDF and SBOMs to penetration testing and documentation — so you can focus on your device, not the paperwork.
Ready to simplify your FDA cybersecurity submission?
Schedule your free Discovery Session today.
✅ FDA Cybersecurity Compliance — Done for You, Guaranteed
Getting FDA cybersecurity right isn’t just about checking boxes — it’s about avoiding costly delays, reducing risk, and getting your device to market without setbacks. For most MedTech teams, it’s overwhelming. We make it effortless.
What’s Included — Fully Managed for You:
📝 Custom, FDA-Ready Documentation
Includes SPDF, risk assessments, mitigation plans, labeling content, and more — fully aligned with the FDA’s latest guidance.
🔐 Penetration Testing & SBOMs
Full-spectrum testing (DAST, SAST), vulnerability scanning, and a complete software bill of materials tailored to your device.
🌍 Global Regulatory Alignment
Built to meet FDA, eSTAR, IMDRF, and EU MDR/IVDR standards — so your submission works across markets.
Why MedTech Teams Choose Blue Goat:
♻️ Unlimited Retesting — Included
Reassessments are free until your submission is fully FDA-ready.
📄 Submission Guarantee
If the FDA flags cybersecurity issues, we resolve them at no additional cost.
💯 Proven Results
100% success rate with FDA cybersecurity submissions — and counting.
Your Path to Stress-Free Compliance:
Book Your Free Strategy Call
We review your device, submission type, and any existing gaps.We Do the Work
Testing, documentation, and compliance — all handled by our team.You Submit with Confidence
No gaps. No guesswork. No delays.
Why Leading Medtech Innovators Choose Blue Goat Cyber
🔬 Specialized in Medical Devices — Nothing Else
For over a decade, we’ve focused 100% on medical device cybersecurity. That means you get true experts — not generalists — guiding your FDA submission from day one.
📊 Proven Results You Can Count On
We’ve supported hundreds of successful FDA submissions, from diagnostics to robotic surgery. Clients trust us when the stakes are high — and deadlines are tight.
🛡 Guaranteed FDA Cybersecurity Approval
If the FDA flags a cybersecurity issue, we fix it — fast, and at no additional cost. That’s our commitment to getting you approved the first time.
🔄 We Stay With You After Approval
We don’t walk away once your device is cleared. Our postmarket support keeps your device protected and compliant as new threats emerge.
❤️ A Mission That’s Deeply Personal
After surviving a life-threatening health event, our founder Christian Espinosa committed his life to protecting the medical devices that protect others. That mission fuels every submission we touch.
Ready to Work With a True FDA Cyber Partner?
Talk with a cybersecurity expert and get clear, actionable guidance for your FDA submission — in 30 minutes or less.
Trusted by Leading Medical Device Manufacturers
We’ve partnered with manufacturers of all sizes—from startups to global leaders—to secure FDA premarket approvals for devices like:
- Robotic surgical systems
- IoT-enabled diagnostic tools
- Implantable medical devices
- Wearable health technology
- Complex IVD systems
- AI-Enabled SaMD
“Blue Goat Cyber handled every aspect of our FDA cybersecurity submission — from threat modeling and SBOMs to testing and documentation. Their team knew exactly what the FDA was looking for and helped us avoid delays, rework, and unnecessary stress. We submitted with total confidence, and our clearance came through without a single cybersecurity question.”
— Director of Regulatory Affairs, Class II Medical Device Manufacturer
“Blue Goat Cyber’s expertise ensured our FDA approval on the first try, saving us time and money.“
— Founder & CEO, Medical Device Startup
“”They resolved our FDA deficiency issues quickly, getting us back on track without delays.”
— Sr. Regulatory Affairs Consultant, Medical Device Manufacturer
Your Path to FDA Compliance Starts Here
Let us handle the complexities of cybersecurity so you can focus on what matters most—patient care and innovation. Blue Goat Cyber’s FDA Compliance Package is your complete solution for navigating 510(k) and PMA cybersecurity requirements with confidence.
Get Started Today:
- Schedule a free Discovery Session.
- Receive tailored guidance for your device’s submission.
- Achieve FDA approval with guaranteed results.
