Looking at various safety standards, risk/benefit analysis is well established in the medical environment (and only there); e.g. ISO 14971 states "If the residu

Looking at various safety standards, risk/benefit analysis is well established in the medical environment (and only there); e.g. ISO 14971 states "If the residual risk is not judged acceptable using the criteria established in the risk management plan and further risk control is not practicable, the manufacturer may gather and review data and literature to determine if the medical benefits of the intended use outweigh the residual risk."