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 don’t understand the unique architecture, patient risks, and regulatory demands of 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 MedTech industry expectations 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:
FDA Cybersecurity Guidance (2023)
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 spent securing diagnostics, robotics, and SaMD, we understand the real-world complexity of medical tech — 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 — the things automated tools miss.
🛡️ 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 mapped to FDA, EU MDR/IVDR, ISO 14971, and IEC 62304 — minimizing the risk of deficiencies, resubmissions, or audit findings.
Our Penetration Testing Process Simplifies FDA Compliance
🔍 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.
Trusted by Medical Device Manufacturers Worldwide
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’s penetration testing gave us FDA-compliant reports and helped us secure approval on the first try. Their expertise saved us significant time and avoided costly delays.”
— Director of Regulatory Affairs, Medical Device Manufacturer
“As a startup, we needed a partner who understood FDA requirements. Blue Goat Cyber delivered beyond expectations, identifying vulnerabilities and providing submission-ready reports.”
— Founder & CEO, Medical Device Startup
“Unlike other firms, Blue Goat Cyber truly understands medical device cybersecurity. Their manual testing and regulatory knowledge ensured our device met compliance and protected patients.”
— VP of Engineering, IoT Medical Device Company
Your Path to FDA-Approved, 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.
