Notified Body Deficiency Response demo
Each notified body question answered from your own technical file, and each repeat shown with what the last answer missed. 1:29
What the demo shows
Deficiency response for EU regulatory teams: notified body questions answered from the file.
The review is drawn as a Round Track: one column per round, one token per deficiency, by technical file part. Agents split the letter, map each item, find the Round 1 question each repeat came from, name what was missing, then draft from the technical file with citations and check tested against released revisions. True gaps get an owner and a date. Post-market items go to the PMS team unread. A maker signs, a second person checks after reading, and the PRRC opens every major, repeat and gap plus a sample before signing the round.
Transcript
- Notified Body Deficiency Response answers notified body questions from your technical file.
- For EU regulatory teams; certificates take thirteen to eighteen months.
- 2.07 repeats 1.12; Nerys asks for a re-read.
- Round 1 sent only results; page 4 says why thirty.
- Both bounds, recomputed and cited.
- Nerys, the regulatory affairs manager, rewrites the opening and signs as maker.
- Yorick, the design quality engineer, must read it to the end; his check unlocks only after the answer has been on screen long enough for its length, then he signs.
- Wystan, the PRRC, reads his last required item to the end as well, then signs Round 2, and the signature records what it means and when.
- Post-market items stay unread; every signature is audited.
- Nineteen cited answers, three owned gaps, six repeats explained.
- Built on Botminds: agents, data, screens and governance on one platform.
The narration as written for the film. Captions are on the player.