Our usability engineering plan defines clear objectives for the usability tests, including the scenarios that are to be tested, critical tasks and functions of the medical device. It also includes the selection criteria for participants in order to ensure a representative user group. The plan details the methods that will be used during the formative and summative studies and complies with the FDA Human Factors Guideline. An essential part of the UEP is the creation of the Use Specification.

The Use Specification is a central document that describes the intended use of the medical device by the user and patient groups. It defines how the product is to be used in the real world. Our experts create a comprehensive use specification that takes all relevant user interactions, critical tasks and context factors into account. This specification forms the foundation for the development of scenarios and tasks during the usability tests.

We initiate the process with an in-depth usability risk analysis that identifies and evaluates critical tasks and scenarios as well as potential risks and threats to the usability of the medical device in accordance with the requirements of IEC 62366 and the FDA Human Factors Guideline.

For the formative studies, we create detailed Formative Usability Study Plans that document all study designs, test objectives and participant selection criteria in accordance to FDA requirements. The results of these studies are recorded in the Formative Usability Test Report, including all methods used and findings obtained.

For summative studies, we develop comprehensive Summative Usability Study Plans that describe the validation of the final product’s usability under real-world conditions of use in accordance with the FDA Human Factors Guideline. The conduct of the study and the results are documented in the Summative Usability Test Report.

All activities and results are recorded in the Design History File (DHF) and the Device Master Record (DMR) in accordance with FDA requirements. This documentation includes risk analyses, study plans, protocols, test results and all applied design improvements and their justifications.