FDA-Ready SBOM Generation & Analysis for Medical Devices
We create, analyze, and manage Software Bills of Materials (SBOMs) to help medical device companies meet FDA cybersecurity requirements — premarket and postmarket.
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
The FDA Now Requires SBOMs — Most Teams Aren’t Ready
The FDA’s latest cybersecurity guidance clearly demands that you include a Software Bill of Materials (SBOM) for every connected medical device.
But for most teams, building a complete, accurate, and compliant SBOM is overwhelming, especially when combined with SPDF requirements, vulnerability analysis, and evolving software supply chain risks.
⚠️ The Cost of Getting SBOMs Wrong Is Too High
💸 Delayed Launches Mean Lost Revenue
Submissions flagged for SBOM issues can delay approval by months — costing millions in market opportunity.
📄 Documentation Deficiencies = Rework and Risk
Incomplete or inconsistent SBOMs are among the top reasons devices face FDA cybersecurity rejections or additional questions.
⚠️ Patient Safety and Reputational Damage
Undocumented vulnerabilities in third-party components can lead to real-world exploits, safety incidents, and loss of trust.
🛡️ Blue Goat Cyber Builds SBOMs That Pass FDA Scrutiny
We’re not a generalist security firm — we focus exclusively on medical device cybersecurity. We build, audit, and manage SBOMs that align with FDA premarket and postmarket expectations, including machine-readable formats, component-level risk tracking, and ongoing vulnerability monitoring.
You get more than a document — you get an FDA-aligned asset that accelerates approval and protects patients.
Includes a 30-minute session with a medical device cybersecurity expert to review your current SBOM readiness and outline next steps — no pressure, just clarity.
Includes a 30-minute session with a medical device cybersecurity expert to assess your SBOM readiness, uncover compliance gaps, and outline your next steps — no obligation.
✅ Getting SBOMs Right Isn’t Optional — It’s Critical to FDA Success
The FDA now expects a comprehensive, accurate Software Bill of Materials (SBOM) for every connected medical device — premarket and postmarket. However, building and managing an SBOM that meets these standards is overwhelming for most MedTech teams.
At Blue Goat Cyber, we make it effortless.
🧬 What’s Included — SBOM Services Fully Managed for You
🧾 FDA-Ready SBOM Creation
We generate machine-readable SBOMs that document all third-party, open-source, and proprietary components — structured to meet FDA premarket cybersecurity guidance.
🔍 SBOM Risk Analysis & Vulnerability Mapping
We assess your SBOM for unsupported software, high-risk dependencies, and known CVEs — providing detailed risk scores and mitigation guidance aligned with FDA and ISO expectations.
📊 Continuous SBOM Monitoring (Postmarket)
Post-launch, we track SBOM components for emerging vulnerabilities and notify you when updates or patches are required — keeping your devices secure and compliant.
✅ Why MedTech Teams Trust Blue Goat Cyber
🔁 Lifecycle Support
From design to postmarket, our SBOM services are built to evolve with your device — not just meet checklist requirements.
📄 Regulatory Alignment You Can Count On
We ensure SBOMs meet FDA, eSTAR, IMDRF, and EU MDR/IVDR standards — no rework, no guesswork.
💯 Proven Track Record
We’ve helped startups and global manufacturers submit confidently — with a 100% FDA cybersecurity success rate.
🚀 Your Path to SBOM Success
1. Book Your Free SBOM Compliance Review
We evaluate your current SBOM strategy, identify gaps, and recommend a clear next step.
2. We Build and Manage It for You
Creation, analysis, tracking, and documentation — handled entirely by our medical device cybersecurity team.
3. You Submit With Confidence
No missing components. No rework. Just an SBOM that works — for the FDA and your patients.
Why Leading MedTech Teams Trust Blue Goat with Their SBOMs
🔬 We Specialize in Medical Device SBOMs — Not Just Cybersecurity
SBOMs for medical devices aren’t a side service — they’re a core part of what we do. With over a decade focused exclusively on medical device cybersecurity, we understand what the FDA expects and how to deliver it — precisely, completely, and on time.
📊 Proven Success Across Complex Devices
We’ve helped secure hundreds of FDA submissions from AI-powered diagnostics to Class III implantables. Our SBOMs are structured, machine-readable, and built to support approval — not just compliance.
🛡 Guaranteed Alignment with FDA SBOM Requirements
If the FDA flags your SBOM during the cybersecurity review, we resolve it — fast and at no additional cost. That’s our promise to help you avoid delays, rework, or deficiencies.
🔄 Ongoing SBOM Monitoring After Approval
Postmarket compliance doesn’t stop at launch. We monitor your software components for emerging vulnerabilities and guide you through mitigation — keeping your devices secure, supported, and compliant year-round.
❤️ Purpose-Driven Protection
After a life-threatening health event, our founder, Christian Espinosa, dedicated his life to securing the devices that save lives. That mission drives every SBOM, every submission, and every step we take with our clients.
Ready to Work With a True FDA Cybersecurity Partner?
Talk with a cybersecurity expert and get clear, actionable guidance for your SBOM generation and analysis — 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.
