Benefit

ISO 14971:2019 made benefit a defined term so that residual risks can be weighed against something concrete. The benefit-risk conclusion in the risk management report rests on it, and the clinical evaluation supplies the evidence.

positive impact or desirable outcome of the use of a medical device (3.10) on the health of an individual, or a positive impact on patient management or public health Note 1 to entry: Benefits can include positive impact on clinical outcome, the patient’s quality of life, outcomes related to diagnosis, positive impact from diagnostic devices on clinical outcomes, or positive impact on public health.

ISO 14971:2019, clause 3.2