With the FDA's final cybersecurity guidance in full effect and QMSR aligned to ISO 13485 taking hold in February 2026, cyber-device submissions face the most rigorous cybersecurity requirements to date. If your device is a cyber device under Section 524B, your premarket submission carries a specific set of documentation through eSTAR.
The trap is not any single document. It is consistency. Your threat model, your architecture views, your SBOM-driven risk assessment, and your controls all have to tell the same story about the same device. Conflicting documentation is what draws deficiency questions, and in the worst case, outright rejection.
A submission does not fail because one document is weak. It fails because the documents disagree.
The fix is a single source of truth for architecture, findings, and dispositions, so every deliverable is generated from the same model instead of assembled by hand across teams and spreadsheets.
Start with one device. We build the twin from documentation your quality system already produces, run AI discovery remotely, and show you the graph: the handful to fix, and the evidence for everything else.
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Nine deliverables: a Cybersecurity Management Plan, Security Architecture Views, a Threat Model, a Cybersecurity Risk Assessment, an Assessment of Unresolved Anomalies, Cybersecurity Metrics, Cybersecurity Controls, Software Interoperability verification and validation, and Vulnerability and Patch Management. If your device is a cyber device under Section 524B, the premarket submission carries all of them.
The FDA's final cybersecurity guidance is in full effect and QMSR aligned to ISO 13485 takes hold in February 2026, so cyber-device submissions now face the most rigorous cybersecurity requirements to date. The documentation set did not just grow, the scrutiny applied to it grew with it.
Inconsistency, not weakness. A submission does not fail because one document is weak. It fails because the documents disagree. The threat model, the architecture views, the SBOM-driven risk assessment and the controls all have to tell the same story about the same device.
Generate them from a single source of truth for architecture, findings and dispositions rather than assembling them by hand across teams and spreadsheets. Documents produced from one model of the device cannot contradict each other, and contradiction is what draws deficiency questions and, at worst, rejection.