IVDR Performance Evaluation Report demo

What the demo shows

A performance evaluation tool for IVD clinical and regulatory teams: claims matched to studies

Agents list every performance claim in the instructions for use, read each study report and scientific source, and match each claim to the study that produced it for value, units, sample type, population and reagent version. A claim with no study or a contradicting study cannot enter the report: it goes to an owner. People decide, a statistician checks a random sample and every decided finding, and four named people sign the report.

Transcript

1. 0:00IVDR Performance Evaluation Report checks each diagnostic test claim against its studies, for IVD teams.
2. 0:10Legacy class C tests may stay on the EU market only until December 31, 2028.
3. 0:19Twenty claims stand, three gaps get owners, and one contradicts: one limit for all adults.
4. 0:28The study reports 14.3 nanograms per liter for women, 31.6 for men.
5. 0:37Ines drafts sex-specific wording; the agents re-check the three claims it touches, and she signs as author.
6. 0:47Konrad, the regulatory affairs manager, must read the three studies behind the change himself before he can approve.
7. 0:55A new cut-off is a significant change for a legacy assay under IVDR.
8. 1:01So he holds it for the IVDR file, and approves.
9. 1:08The audit trail records who signed, when and why.
10. 1:13Twenty-one of 24 claims are ready; touched claims carry the new wording.
11. 1:19Built on Botminds: agents, data, screens and governance on one platform.

The narration as written for the film. Captions are on the player.