SS(C)P operations without losing the evidence trail
SS(C)P work is not just a document-upload task. It sits across manufacturer responsibility, Basic UDI-DI relationships, translations, notified-body validation context and downstream publication operations.
ClinicOps organises that evidence into a traceable work plan, with duty-holder context and unresolved questions kept visible.
Regulatory boundary
Under MDR Article 32, the manufacturer is the duty holder for drawing up the SS(C)P for applicable implantable and class III devices, subject to the Article 32 exclusions. ClinicOps does not replace that responsibility; it is the evidence and operations layer around the work.
What ClinicOps can organise
EUDAMED operating model
MDCG 2026-4 describes a revised EUDAMED operating model in which the manufacturer uploads the SS(C)P master version and translations, while the notified body indicates the validated SS(C)P against the relevant Basic UDI-DI(s). The model is non-binding MDCG guidance tied to the new EUDAMED functionality; verify it against current production behaviour before relying on it operationally.
Good fit
Manufacturers managing several SS(C)Ps and translations; authorised representatives that need portfolio visibility; regulatory teams preparing an evidence-led operational handoff; consultancies that want a repeatable reconciliation layer.
Deliverable
An engagement returns an evidence inventory, an unresolved-source register, Basic UDI-DI / SS(C)P relationship questions, a translation and handoff matrix, and prioritised human-review actions. A missing public field is never treated as a non-compliance finding on its own.
Related
Start with one portfolio
One SS(C)P family or a small portfolio is enough. ClinicOps shows what reconciles, what stays unresolved and where authoritative evidence is needed.