EU MDR Technical Documentation Review demo
Every Annex I requirement checked against the technical file, with the document and page that meets it or the gap that does not. 1:13
What the demo shows
A device regulatory solution that checks EU MDR technical files against the GSPR checklist.
Agents index the technical file, map each Annex I requirement to the document, standard and page that meet it, read the same facts from every document and show the ones that disagree side by side, and draft the review report; a regulatory lead decides and signs.
Transcript
- EU MDR Technical Documentation Review checks device technical files against Annex I for regulatory teams.
- Legacy devices need MDR certificates by 2027 and reviews take over a year.
- Five agents tie every requirement to a document and page.
- Rings are Annex I sections.
- Empty arcs are gaps, red notches contradictions.
- Labels and instructions sit at 80%.
- Ingrid opens a notch.
- Shelf life is 36 months in the design file, 24 on the label.
- The March change record missed the label artwork.
- She aligns the label and assigns the change before the notified body asks.
- Files that pass notified body review the first time.
- Built on Botminds: agents, data, screens, and governance on one platform.
Transcribed from the film’s narration. Captions are on the player.