Reviewers in medical device, financial services and other regulated settings want to see how you know the model works, for whom, and what happens when it does not. The questions differ in wording but rarely in substance. These five come up again and again.

1. Who Is This Model For, and Was It Validated on Them?

Evidence that answers it: a written intended-use statement, a description of the training, validation and test datasets (source, size, time period, labelling method), and a comparison showing the validation population matches the intended users.

2. How Does It Perform for the Groups That Matter, Not Just Overall?

Evidence: results broken out by the subgroups relevant to your use, such as age, sex, site, device or equipment type, with acceptance criteria agreed before the test. A single overall figure that hides weak performance in your largest user group is the most common gap.

3. What Happens When It Is Wrong, and Who Finds Out?

Evidence: the AI-specific failure modes in your risk file, how errors are detected in use, how a human can override or escalate, and what is monitored after release.

4. What Changes After Release, and Who Approves It?

Evidence: model versioning, change control, retraining triggers, and where applicable a predetermined change control plan that sets out in advance what may change and how it will be verified.

5. Who Has Looked at This Independently, and What Exactly Did They Look At?

Evidence: a written scope, the criteria used, the evidence reviewed, the date, and what was not covered. Teams answer this question worst, because an independent opinion is only as meaningful as its stated scope.

// A NOTE ON SCOPE

That is why ClearanceAI states its scope plainly. Our Readiness Verified designation reflects an independent, scope-limited assessment of specified criteria and available evidence at the time of review. It is not a product safety certification, regulatory approval, or warranty of performance. A reviewer should be able to read the scope and know exactly what the assessment does and does not tell them.

A Quick Test

Take the five questions above and try to answer each one today with a document you could hand to a reviewer. The ones you cannot answer are your gap list, and the cheapest time to find them is before someone else asks.

See what a finding looks like in our sample report.