Acquisition Quality System and Design File Integration demo
Each acquired product family read as it is, mapped to your procedures clause by clause, and moved only when every gap has an owner. 1:29
What the demo shows
An acquisition integration tool for device quality and regulatory teams: files mapped by family
Agents sort the data room into product families and file cars, map each document to the buyer's procedures through ISO 13485 clauses, check design files, clearances, registrations, supplier agreements and labels against the buyer's rules, and write each gap with its pages. Owners own or close each gap with a second person; a family moves only when every car couples, with regulatory approval and the integration lead's signature.
Transcript
- Acquisition Quality System and Design File Integration brings an acquired device maker's files into your system.
- For regulatory and quality leads: registration updates are due in 30 days.
- Each family is a train of file cars: 48 couple; 24 hold gaps.
- Family 4: instructions say 3 millimeters; both clearances, 4 to 10.
- The agent cites both pages and leaves the decision to a person.
- Theron from regulatory logs it: assess a new 510(k); cleared wording meanwhile.
- Rhoswen, a second regulatory reviewer, opens his log and checks it before anything moves.
- She approves the plan's filings, while the 3 millimeter wording stays blocked from labels.
- Then Liliane, the integration lead, reads the plan and signs; each signature records its meaning.
- Family 4 moves on January 11, its gap checked.
- Built on Botminds: agents, data, screens and governance on one platform.
The narration as written for the film. Captions are on the player.