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.