High-level • High-level • Implementation is shared privately

Submission Ops operating layer

This page explains what the operating layer does — not the enabling mechanics. We keep public materials at a high level.

One controlled dataset goes through readiness gates and becomes submission‑ready outputs with an audit‑friendly handover narrative.

InputScope + controlled dataset

NormalizeOne canonical record

ValidateCompleteness + consistency checks

PackageUpload-ready exports

EvidenceVersioned handover pack

Lower avoidable rejectsCatch missing/inconsistent data before submission.

Shorter cycle timeReplace rework loops with repeatable gates.

Calm audits“What changed / why / who approved” stays explainable.

Detailed packs, mappings, and enabling mechanics are shared in a private engagement only (limited detail sharing; selective sharing as needed).

Where it applies

UDI Ops (EUDAMED + swissdamed), actor/SRN pathways, and other repeatable submission workflows.

Next step

Start with a readiness scan and acceptance criteria; then produce the minimum viable submission pack.

Public governance

How we publish structure‑only materials without leaking implementation IP: guardrails, claims discipline, and anonymization checks.

Audit‑grade by default

Why even public downloads include integrity manifests + checksums (and how to verify in 1 minute).