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Use Case 02 — NB Submission Preparation

Notified Body submission.
Centrally managed.

A Notified Body submission requires complete, consistent, and traceable documentation — across every department. Confideck brings every team, every document, and every open item into one central environment so your submission is complete before it leaves the organisation.

RA Leader PRRC Quality Clinical Affairs
40%

Reduction in submission preparation time

How it works

One place for every team,
every task, every document.

01
Submission project created
A structured submission project is set up in Confideck — scoped to the notified body, jurisdiction, and product. All relevant documents are linked from the start.
Project setup
02
Tasks assigned inside documents
Each open item — a missing section, an outdated reference, a required sign-off — is assigned directly inside the document context. No external task tools. No email chains.
In-document tasks
03
Departments aligned in real time
RA, Quality, Clinical Affairs, and PRRC all work in the same environment. Every contributor sees what is open, what is done, and what is blocking submission.
Cross-dept alignment
04
Submission package assembled
When all items are resolved, Confideck generates a structured, complete submission package — formatted for the notified body, source-linked, and audit-ready.
NB-ready package

The outcome

What changes when submission
is a managed process, not a sprint.

40%
Reduction in preparation time
Structured project management inside the documents eliminates coordination overhead across departments.
0
Surprises during NB review
Every gap is identified and resolved before the package leaves the team — not discovered during the notified body assessment.
1
Complete, structured package per submission
Formatted for the notified body, source-linked, and audit-ready. Not a folder of files — a submission.