GessNet presented a tutorial at IMSC26 on turning risk files into a clear, credible safety story -- moving beyond a compliant-looking risk management file to one that actually demonstrates, to a reviewer or regulator, that the residual risk of a medical device is acceptable.
The tutorial addressed a recurring gap the GessNet team has observed across many risk management files: hazards, controls, and evidence that are individually well-documented but not connected into an argument that explains why the product is safe and effective as a whole.
The session outlined a practical structure for organizing risk information -- hazard, harm, cause, control, and verification evidence -- so a reviewer can follow the reasoning from hazard to residual-risk conclusion without reconstructing it themselves.