Evaluate residual risk and benefit-risk

After controls are applied, the remaining risk must be evaluated. The file should explain the acceptability criteria and how each residual risk was judged against them.

For risks that are not individually acceptable, a benefit-risk rationale may be needed. That rationale should be tied to clinical benefit, intended purpose, user needs, and available alternatives.

Avoid generic statements such as “benefits outweigh risks” without evidence. The expert will look for the specific benefits, risks, assumptions, and supporting data behind the conclusion.