Full-Service MedTech Cybersecurity
FDA-Compliant Vulnerability & Penetration Testing for Medical Devices
Struggling to meet the FDA’s cybersecurity testing requirements? We identify vulnerabilities and deliver FDA-ready reports — fast, accurate, and aligned with current guidance.
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
Why Most Pen Testing Fails Medical Devices — and How We Fix That
⚠️ Generic Testing Doesn’t Work for Medical Devices
Most penetration testing firms lack an understanding of the unique architecture, patient risks, and regulatory demands associated with medical devices. Their reports may be thorough — but not FDA-compliant.
This often leads to:
❌ Incomplete Testing
Missed vulnerabilities in embedded systems, wireless protocols, or proprietary medical interfaces.
📄 Non-Compliant Reports
Documentation that fails to meet FDA premarket expectations — causing delays, rejections, or deficiency letters.
⚠️ Increased Patient and Product Risk
Overlooked vulnerabilities that compromise safety, device functionality, or user trust.
✅ We Specialize Where Others Fall Short
At Blue Goat Cyber, we focus exclusively on medical device cybersecurity — from testing to documentation. Our work aligns with FDA guidance, AAMI TIR57, ISO 14971, ISO 13485, and the latest expectations of the MedTech industry for SPDF and vulnerability management.
You’re not just getting a scan. You’re getting FDA-ready penetration testing — done right the first time.
Need FDA-Compliant Penetration Testing?
Book your free Discovery Session today.
Talk with a medical device cybersecurity expert and get a tailored plan for your testing and documentation — fast, focused, and FDA-aligned.
We Don’t Just Understand FDA Cybersecurity — We Live It
At Blue Goat Cyber, medical device cybersecurity isn’t one of many services — it’s all we do. That focus means you get a partner who not only performs deep technical testing, but also understands how to translate those results into FDA-compliant documentation that regulators trust.
We align every test and report with:
AAMI TIR57 (Threat Modeling & Risk Management)
IEC 62304 (Medical Device Software Lifecycle)
ISO 14971 (Risk Management for Medical Devices)
✅ Why It Matters to You:
You avoid costly rework or submission delays
Your documentation speaks the FDA’s language
Your device is tested with patient safety and compliance in mind
How We’re Different
📄 FDA-Ready Reports — No Rewrites Needed
We deliver detailed, submission-ready documentation tailored to the latest FDA cybersecurity guidance — saving you time, revisions, and review delays.
🩺 Exclusive Focus on Medical Devices
With over a decade of experience securing diagnostics, robotics, and SaMD, we understand the real-world complexity of medical technology — not just theoretical threats.
🔍 Manual Testing Where It Matters
We go beyond scanners. Our manual logic testing uncovers deep vulnerabilities in firmware, connectivity layers, and device behavior — areas that automated tools often miss.
💰 Fixed-Fee Engagements, No Surprises
You get clear, upfront pricing for the entire engagement — so you can budget confidently without worrying about change orders or hidden costs.
🔁 Unlimited Retests Until You Pass
We include unlimited retesting for identified findings, helping you validate fixes, strengthen your security posture, and navigate regulatory reviews with confidence.
🛡️ Patient Safety Drives Everything We Do
We don’t just check boxes — we test for real-world risk. Our mission is to help you protect patients while meeting the highest regulatory standards.
🌍 Built for Global Regulatory Success
Our testing and documentation are aligned with FDA, EU MDR/IVDR, ISO 14971, and IEC 62304 standards, minimizing the risk of deficiencies, resubmissions, or audit findings.
Our Penetration Testing Process Simplifies FDA Clearance
🔍 1. Discovery Session — Clarify Scope and Risk
We kick off with a focused session to understand your device, its intended use, connectivity, and regulatory path (510(k), PMA, De Novo) — ensuring your testing aligns with both FDA and clinical risk.
🧠 2. Custom Testing Plan — Built Around Your Device
Our team designs a tailored penetration testing strategy for your specific architecture, embedded systems, wireless protocols, and data flows — no boilerplate, no gaps.
⚔️ 3. Rigorous Testing — Simulate Real-World Threats
We perform deep manual and automated testing, using real-world attack techniques to identify vulnerabilities that could impact functionality, safety, or data integrity.
📄 4. FDA-Ready Reporting — No Edits Needed
You’ll receive submission-ready documentation that includes detailed findings, risk ratings, and mitigation recommendations — formatted to meet FDA cybersecurity expectations.
🛡️ 5. Post-Test Support — Stay Submission-Ready
We stay with you through the FDA process, responding to any questions, clarifying documentation, and ensuring your submission isn’t delayed due to cybersecurity gaps.
We’ll scope your device, outline your testing strategy, and show you exactly how we help you submit with confidence — no pressure, just clarity.
We’ve partnered with manufacturers of all sizes—from startups to global leaders—to secure over 200 FDA and global premarket clearances 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-Cleared, Secure Devices Starts Here
Don’t risk delays or deficiencies in your premarket submission. Partner with Blue Goat Cyber to ensure your devices meet FDA cybersecurity standards, protect patients, and earn trust in the marketplace.
Blue Goat Cyber's Medical Device Penetration Testing Service FAQs
Medical device penetration testing simulates real-world attacks to identify vulnerabilities that could compromise patient safety, device functionality, or data security, and documents the evidence in a format compliant with FDA regulations.
Testing can be tailored to your device architecture, including embedded/firmware components, connectivity layers (such as wireless protocols), data flows, and supporting applications/APIs, where applicable.
Yes—Blue Goat positions the deliverable as “FDA-ready reports” designed to align with current FDA cybersecurity guidance and reduce rewrites and review friction.
It’s not just scans. Blue Goat emphasizes manual testing where it matters, to uncover deeper issues that automated tools often miss (such as logic, firmware behavior, and connectivity).
Usually: architecture details, intended use/deployment environment, connectivity and data flow information, test builds (or access method), and any existing cybersecurity documentation. The discovery session is used to confirm the scope and identify risks.
Our medical device penetration service aligns with current FDA cybersecurity guidance and common medical technology standards (e.g., ISO 14971, IEC 62304, UL 2900, AAMI TIR57/TIR97, NIST 800-115, ISO 13485, IEC 81001-5-1, and others).
Yes—Blue Goat explicitly ties scoping and reporting to your regulatory path (510(k), PMA, De Novo), so the testing evidence is submission-relevant.
Yes. Findings include risk ratings and mitigation recommendations, and Blue Goat stays engaged post-test to help you remain submission-ready.
Yes—Blue Goat states they include “unlimited retests until you pass,” so you can validate fixes and strengthen your evidence package.
Blue Goat positions engagements as fixed-fee (“no surprises”), so you can budget without change orders or hidden costs.
Yes—post-test support includes helping answer FDA questions, clarifying documentation, and preventing delays due to cybersecurity gaps.
Timelines depend on device complexity, scope (device-only vs. ecosystem), and test access (lab setup, builds, and credentials). Most engagements follow a clear flow—scoping → testing → reporting → remediation support/retest—so we’ll confirm a schedule and key milestones during the discovery call to match your FDA submission timeline.