MBC Technology Group
Industry · Medical Devices

Medical device security that stands up to FDA scrutiny.

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

Talk to an expert How we help →
What we secure

The whole device — not just the app.

Embedded & firmware

Device hardware, RTOS and firmware, wireless interfaces — tested by our IoT/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 your submission needs.

Postmarket vigilance

Vulnerability monitoring, coordinated disclosure and response plans that satisfy postmarket guidance.

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

Test before submission. Watch after launch.

Before submission

+Device & firmware penetration testing
+Threat modeling & security architecture review
+SBOM & submission evidence preparation
+Gap assessment against FDA expectations
Penetration testing →

After launch

+24/7 monitoring of device cloud infrastructure
+Vulnerability intake & response plans
+Incident response retainers
+Postmarket evidence for regulators
24/7 AI-Powered SOC →

Preparing a submission — or maintaining a fleet in the field?

Talk to an expert
MBC Technology Group

Accelerating customer success through secure AI adoption and cloud modernization.

info@mbctg.com +1 (855) 217-3575 2800 Euclid Ave, Cleveland OH
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