ISO 14971 Risk Management File Review demo
The risk file drawn as a rack of hazard chains: every control matched to the report that proves it, every warning found in every language, and a change re-checking only the chains it touches. 1:28
What the demo shows
A risk management file review solution for device makers: hazard chains checked to their proof.
Agents build one chain per hazardous situation from the hazard analysis and the FMEAs, and check each link against the firm's own documents: the verification report at its current revision, the residual risk under the plan, and the disclosing sentence in every language version of the instructions for use. When document control releases a change, they re-check only the chains that pass through the changed passages and clear the review signature that rested on them. Labeling restores or writes the fix, a second person checks a random sample of the chains the agents called whole, and the risk management lead approves the review. Post-market information arrives as one signed reference that the agents never read.
Transcript
- Risk Management File Review checks hazard chains against their evidence.
- For risk teams: one IFU revision touches 103 of 318 chains.
- H-117 opens: its only control, the warning, is gone.
- Florentyna, the labeling specialist, reads both revisions and restores the approved warning in all 11 languages.
- Only that chain is re-checked.
- Next, Leocadio, in design quality, signs in as himself, opens three chains beside their sources, reads each one, and signs the sample.
- Corisande, the risk management lead, reads the packet and rules that the usability evidence still applies.
- She checks the overall residual risk herself and approves the file.
- Every signature records who, when and why.
- Result: 103 chains re-checked; the change order can release.
- Built on Botminds: agents, data, screens and governance on one platform.
The narration as written for the film. Captions are on the player.