Industry · Medical Devices

Medical device security, from threat model to postmarket plan.

Premarket cybersecurity documentation, embedded and connectivity testing, and postmarket vigilance for device makers, from firmware to the cloud back end.

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What we secure

The whole device, not just the app.

Embedded & firmware

Device hardware, RTOS and firmware, and wireless interfaces, tested by our IoT and embedded pen test team.

Connectivity & cloud

Companion apps, APIs and telemetry back ends that carry patient data.

Premarket documentation

Threat models, SBOMs, security testing evidence and the §524B artifacts for your submission.

Postmarket vigilance

Vulnerability monitoring, coordinated disclosure and response plans aligned with FDA postmarket guidance.

Mapped to: FDA §524B FDA Premarket & Postmarket guidance ISO 27001 MITRE ATT&CK How we deliver compliance →

The plant that builds it.

Production lines, test benches and the IT systems they depend on. Passive OT visibility and segmentation for the lines that build your product.

OT security for manufacturing →Managed OT SOC →

How we help

Test before submission. Watch after launch.

Understand

Model the device

Threat modeling & security architecture review
Device & firmware penetration testing
Gap assessment against FDA expectations

Penetration testing →

Fix

Help implement the approved fix

Remediation guidance and support for your engineering team
Vulnerability intake & response plans
Incident response retainers

Incident response →

Verify

Verify the result

Retest of fixed findings
SBOM & submission evidence preparation
24/7 monitoring of device cloud infrastructure and postmarket evidence

24/7 AI-Powered SOC →

Selling modules or components into the EU? What the CRA covers, and what it does not. →

From premarket submission to devices in the field.

Tell us the device, its connectivity and your submission stage.

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