Clinical evaluation: connect the claim to the evidence

Editorial draft · Sample article for design review

Bring the product definition into view

A clinical evaluation needs a clear account of the device, its intended purpose, and the claims being assessed. Inconsistencies elsewhere in the documentation can make that task harder.

Organize the evidence around the questions

Start by identifying what each claim requires the evaluation to address. This helps the team distinguish relevant evidence from material that adds volume without resolving the question.

Keep the documentation connected

When the device description, risk analysis, or claims change, review the consequences for the clinical evaluation and the associated postmarket plans.