Software safety evidence for the most regulated code there is

Medical device software now needs security evidence to reach the market: regulators expect SBOMs, vulnerability management, and a credible security lifecycle. Hospital systems face the same pressure from the operations side. SecuNexa and BOMNexa produce that evidence without patient data or proprietary code ever leaving your control.

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What changed in healthcare

Premarket cybersecurity is law

In the US, device submissions must address cybersecurity, including software bills of materials and plans for handling vulnerabilities post-market.

Devices live for decades

A component shipped today must be trackable against vulnerabilities disclosed years from now, without rescanning devices in the field.

Clinical networks are closed

Hospital and manufacturing environments restrict connectivity hard, which most modern security tooling quietly assumes.

How SecuNexa answers it

Submission-grade BOMs

BOMNexa generates software and cryptography BOMs from your actual build artifacts, with known-unknowns declared, ready to attach to regulatory submissions.

Post-market monitoring without rescanning

Shipped builds are re-evaluated automatically as new vulnerabilities are disclosed, giving you the affected-device answer regulators expect you to have.

Full lifecycle scanning

Code, dependencies, embedded components, and the APIs and mobile apps around the device, all analyzed inside your network.

Frequently asked questions

Does this satisfy FDA SBOM expectations?

BOMNexa produces machine-readable SBOMs with the component, dependency, and support-status information premarket guidance describes, and its drift monitoring supports the post-market vulnerability obligations. Your regulatory team owns the submission; we make the technical evidence real.

What about legacy devices already in the field?

If you can produce or reconstruct an inventory for a fielded version, BOMNexa monitors it against new disclosures like any other build, no rescan required.

See how this works in an environment like yours.

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