ISO 14971:2019In development
Risk Management
The ISO 14971 risk file as a governed workflow: hazards, controls and residual risk linked to the evidence that proves them.
IN THE PLATFORM TODAY
The Risk Management Plan is drafted in the technical file today. The dedicated workflow engine described here is in development.
What the dedicated workflow will add
In development. Planned scope, honestly labelled.
Hazard and hazardous-situation capture with structured harm chains.
Risk controls linked to the evidence and verification that prove them.
Residual-risk and benefit-risk documentation drawn from the same record.
The same seal-and-currency governance as the rest of the file: a risk file that drifts from its inputs says so itself.