Biological Evaluation Plan and Report (ISO 10993) demo
Each device family's body contacts mapped, every endpoint cited, and a material change replayed so only what rests on it reopens. 1:27
What the demo shows
ISO 10993 biological evaluation plans and reports for device toxicologists, each endpoint cited
Agents draw each family's contacts on a body outline, list the endpoints the plan must address and cite how each is covered. When a material changes, they trace it to the evidence made with it and the rows resting on that evidence: rows on its chemistry reopen at once, rows tested on the finished device are tied to one comparison study, and the rest stay closed with their sources. The toxicologist opens each reopened row, adds the study and signs the plan; closures wait for the head of biocompatibility. Agents never conclude that a device is safe and never read complaint records.
Transcript
- Biological Evaluation Plan and Report keeps each device family's ISO ten-nine-ninety-three evaluation, for toxicologists and biocompatibility teams.
- One colorant change can reopen it; the standard itself changed in November 2025.
- Agents trace each justification to the material it rests on.
- Four rest on the old tubing chemistry and reopen; eight stay closed.
- Ansel drafts plan revision D, every line cited.
- Dr. Kerimova reads each reopened row in full, with its sources and its trace.
- Each one shows the evidence it rests on and why the change reopened it, so she reads it, not skims it.
- Signing stays locked until she has read all four; then she adds the study and signs.
- Noor logs the filing question; every signature is in the audit trail.
- One change: four rows reopened, not the whole evaluation.
- Built on Botminds: agents, data, screens and governance on one platform.
The narration as written for the film. Captions are on the player.