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, resulting in millions of dollars in lost 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 cybersecurity 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 clearance and protects patients.
Includes a session with a medical device cybersecurity expert to review your current SBOM readiness and outline next steps — no pressure, just clarity.
Includes a 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 Clearance
The FDA now requires a comprehensive and accurate Software Bill of Materials (SBOM) for every connected medical device, both 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 and global 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.
We’ve partnered with manufacturers of all sizes—from startups to global leaders—to secure FDA premarket clearance for devices like:
- Robotic surgical systems
- IoT-enabled diagnostic tools
- Implantable medical devices
- Wearable health technology
- Complex IVD systems
- AI-Enabled SaMD
Recent Client Feedback
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 clearance with guaranteed results.
Blue Goat Cyber's SBOM Service FAQs
We deliver FDA-ready SBOM creation, plus SBOM risk analysis and vulnerability mapping, and an option for continuous postmarket monitoring. The goal is an SBOM you can use for both premarket submission and ongoing security management.
Yes. We generate machine-readable SBOMs that are structured to meet FDA cybersecurity expectations for connected medical devices.
Yes. Your SBOM is built to document third-party, open-source, and proprietary software components so your inventory is complete and defensible.
Yes. We assess for unsupported software, high-risk dependencies, and known CVEs, then provide risk scoring and mitigation guidance aligned with FDA and ISO expectations.
That’s the point. The service is positioned to create SBOMs that align with FDA premarket and postmarket expectations and are intended to “pass FDA scrutiny.”
Yes. Blue Goat SBOMs are aligned to meet FDA, eSTAR, IMDRF, and EU MDR/IVDR standards, minimizing rework across regions.
Yes. Post-launch, we track SBOM components for emerging vulnerabilities and notify you when updates or patches are needed to help keep devices secure and compliant.
It starts with a free SBOM compliance review, then we build/manage the SBOM and supporting documentation, and you submit with confidence using a complete, review-ready SBOM.
If the FDA flags your SBOM, we'll resolve it fast and at no additional cost—to reduce delays, rework, and deficiencies.
Blue Goat focuses on medical device cybersecurity, and positions SBOMs as an FDA-aligned asset—not just a generated file—supported by lifecycle services from premarket through postmarket.
SOUP typically refers to third-party or legacy software where a complete development history is not available. An SBOM helps you identify and track those components, then manage the associated cybersecurity and lifecycle risks.
No. An SBOM is an inventory of software components (name/version/supplier/dependencies), not your source code. FDA does not require you to submit source code, and SBOM sharing can be controlled (e.g., provided under NDA or limited-access delivery).