Page 199 - Safety Risk Management for Medical Devices

178 Safety Risk Management for Medical Devices

20.2 INDIVIDUAL AND OVERALL RESIDUAL RISKS
In a quantitative risk management method, such as the BXM method, the
per-Hazard, per-Hazardous Situation, and overall residual risks can be computed using
Boolean algebra, and evaluated automatically.
For qualitative or semiquantitative methods, the manufacturer would need to
create internal policies for the determination and evaluation of risks.