Performance Evaluation Templates

The Performance Evaluation Report outlines the methodologies and outcomes concerning the scientific validity, analytical performance, and clinical performance. A dedicated standard for this is EN 13612:2002, which is concise and does not contain extensive details. Additionally, there are three IMDRF […]

The Performance Evaluation Plan outlines the resources and procedures for assessing the IVD’s performance. A separate standard exists for this: EN 13612:2002. It is brief and doesn’t provide extensive detail. You can generally grasp its contents by reviewing the table