Risk management in the context of ISO 14971 refers to a process for “identifying hazards associated with a
medical device, estimating and evaluating associated risks, controlling these risks, and assessing the effectiveness
of the control.”
Hazard means any potential source of harm to the patient or consumer. Risk refers to a combination of the severity
of the harm and the probability of its occurrence. Risk control is the process of implementing protective measures for
reducing risks or keeping them to a minimum.
