What a pilot looks like.
A pilot is one approved change or one product family, a declared evidence population, a named owner on your side, and timing agreed in writing on day 0. It is a bounded way to see the Regulatory Change Integrity Review on your own records.
Scope
The records, devices or documents in scope are compared against the surfaces you declare: EUDAMED, UDI data, certificates, SS(C)P, labels, IFUs, declarations and controlled records. The size of the scope is agreed with you at the outset. Price is quoted after the scope brief.
How a pilot runs
Timing and scope are agreed in writing on day 0 and depend on how complete the evidence is. Timing pauses while evidence is outstanding, so a complete evidence pack keeps it short. The sequence below is the order of work, not a guaranteed schedule.
| Stage | What happens |
|---|---|
| Scope | Scope agreed in writing: approved source, surfaces, evidence route and your named regulatory owner. |
| Intake | Controlled intake of the exports and records inside that scope. |
| Comparison | Deterministic comparison: source register, change-surface matrix and exception queue. |
| Triage | Triage with your owner. Each exception is assigned; where an exception needs it, ClinicOps can involve independent specialists, by agreement with you. |
| Delivery | Closure packet delivered as a readable report and a machine-readable export. |
What you receive
An exception queue, not a score. Each row carries source, expected, observed, status, evidence, owner, next action and closure. Statuses use this vocabulary: aligned, mismatch signal, missing evidence, conflicting evidence, unresolved, not applicable and requires qualified review.
See illustrative samples on fictional data in the specimen register (a simplified illustration) and the transition map sample. The full deliverable is described on the review page.
Before you start
Use the evidence pack checklist to gather the exports and records in one controlled batch.