Medical Device Security Testing
Firmware and device security validation to meet FDA premarket submissions and ISO 13485 standards.
Last reviewed by Rhitik Kumar, Lead Offensive Security Engineer.
Scope of Assessment
We audit medical devices — patient monitors, infusion pumps and implantable hardware. We check firmware encryption, test wireless networks, and map security structures to satisfy FDA premarket guidelines.
Engagement Details
How the engagement runs
- 01
Scoping and regulatory alignment
We confirm the device, its firmware, the companion app and cloud services in scope, and which submission or standard the evidence must support.
- 02
Firmware and software analysis
Firmware is analysed for weak cryptography, hardcoded credentials, unsigned updates and vulnerable third-party components, with an SBOM produced alongside.
- 03
Wireless and interface testing
Bluetooth, NFC, Wi-Fi and wired service interfaces are tested for pairing weaknesses, unauthenticated commands and exposed diagnostic access.
- 04
Reporting for submission
Findings are documented in a form that maps to FDA premarket cybersecurity guidance and supports your risk management file.
What you receive
- Security testing report structured for premarket submission
- Software Bill of Materials for the device firmware
- Wireless and interface findings with device evidence
- Threat model and risk analysis inputs for your quality file
- Retest report after remediation
Frequently Asked Questions
Do you prepare reports for FDA audits?
Yes. Our final reports match FDA premarket cybersecurity guidelines to simplify compliance.
Do you submit to the FDA on our behalf?
No. We produce the security testing evidence and documentation; your regulatory team owns the submission itself.
Is an SBOM included?
Yes. A CycloneDX or SPDX Software Bill of Materials for the device firmware is part of the deliverable, since premarket guidance expects one.
Can you test a device still in development?
Yes, and it is far cheaper than finding the same issues after design freeze. Pre-production units and release candidate firmware are both workable.
Related security services
Let's map out your testing strategy.
Have a custom compliance framework or specific targeting parameters? Schedule a scoping session with our senior offensive leads.