Security testing for medical devices that saves lives
Extra Security combines hands-on hardware expertise with AI-driven analysis to deliver FDA-compliant penetration testing for medical device manufacturers. Identify vulnerabilities before they become patient safety events, and get the code fixes to resolve them.
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Your device isn't generic. Neither is our testing.
Every medical device has a unique threat profile based on its intended use, connectivity, and patient interaction. We build a custom testing methodology for each engagement so you get findings that matter to your device, not a recycled checklist.
An insulin pump, a cardiac monitor, and a diagnostic imaging system all face different risks. Our methodology adapts to yours, giving you results, not noise.
Device-Specific Scoping
Attack surface analysis based on your device's architecture, communication protocols, and clinical context.
Targeted Test Cases
Test cases derived from your device's threat model and intended use environment, not a one-size-fits-all script.
Patient Impact Analysis
Every finding is assessed for clinical impact, so your team can prioritize what matters most to patient safety.
Signal, Not Noise
No padded reports with irrelevant findings. Every vulnerability in your report is relevant to your device and its regulatory context.
Full-Stack Assessment
Comprehensive testing across all attack surfaces: network, firmware, cloud, and physical. Every finding contextualized to your device's intended use. One unified report mapped to FDA 510(k) requirements. Results that matter, not generic noise.
What we test
Comprehensive security coverage across all attack surfaces defined in FDA premarket cybersecurity guidance.
Network Security
Assess Wi-Fi, Bluetooth, BLE, Zigbee, cellular, and other wireless and wired communication protocols for vulnerabilities that could expose patient data or allow unauthorized device control.
Firmware Analysis
Deep reverse engineering and binary analysis of device firmware to identify hardcoded credentials, cryptographic weaknesses, unsafe update mechanisms, memory corruption vulnerabilities, and insecure boot configurations.
Cloud Security
Assess cloud-connected components, APIs, and backend infrastructure that interface with your device to ensure end-to-end security from device to cloud.
Physical Security
Hands-on testing in our dedicated hardware lab, augmented by AI-driven analysis for faster, deeper coverage. We evaluate tamper resistance, debug interfaces, and physical access controls with the rigor of manual testing at the speed of automation.
Built for FDA submission
The FDA now requires evidence of security testing as part of premarket submissions. A third-party penetration test demonstrates that your device has been assessed against real-world attack scenarios, a key component of 510(k) cybersecurity documentation.
- Mapped to FDA premarket cybersecurity guidance
- Findings mapped to your device threat model
- Custom methodology tailored to each device and use case
- Coordinated vulnerability disclosure assistance
- Dedicated hardware lab for physical device testing
How it works
From scoping to final report. A streamlined process built for medical device manufacturers.
Scope & Schedule
Complete our online scoping form with device specifications, FDA classification, and testing preferences. Pricing is transparent and instant, no waiting for quotes.
Ship Your Device
Upload your source code or firmware files and ship your physical device to our dedicated hardware lab for hands-on testing.
Get Your Report
Receive a detailed pentest report with vulnerability findings, risk ratings, and suggested code fixes. Not just what's wrong, but how to fix it. Formatted for FDA submission.
Re-Test & Verify
After your team applies fixes, request a re-test directly from the portal. AI-accelerated re-testing verifies your remediations in days, not weeks. Included with every engagement.
Your security partner, not just a vendor
Every engagement lives in our platform, giving you full visibility from kickoff to final report and beyond. We're here for every device, every year.
Real-Time Progress
Track every phase of your engagement as it happens, from device intake to testing milestones to report delivery.
Direct Communication
Message our security team directly through the platform. Ask questions, provide context, and stay aligned throughout testing.
All Reports, Anytime
Draft reports, final reports, and re-testing reports are stored in your portal and available for download at any time.
Multi-Device, Multi-Year
Manage security testing across your entire device portfolio. One platform for every engagement, every product line, every year.
Code-Level Remediation
Every finding includes suggested code fixes and patches your engineering team can apply directly. Not generic advice, actionable changes you can merge. Spend less time interpreting results and more time shipping secure code.
Ready to secure your device?
Create an account, scope your engagement online, and ship your device, all from the Thrombus portal.
Create your account