Usability tests

Application devices are devices used to administer medicines. They include, for example:

• inhalers
• syringes, pens, infusion sets
• medical devices for the preparation of suspensions or solutions
• infusion and nutrition pumps, including accessories

In a usability test, we test whether patients can properly use the application devices within the confines of the product-specific requirements. Prior to testing, the safety-relevant steps and the test design are defined in the study protocol, in accordance with the needs of the product. The application devices are tested using carefully selected volunteers as per the predefined and standardised procedure. Each step is subjected to a process of careful analysis, then recorded and evaluated before its final description in the study report.