Usability Testing for Medical Devices in Accordance with IEC 62366-1

Test usability in a home environment under real-world conditions.

We recruit users based on the designated user groups and product-specific requirements.

We assist companies in planning and conducting usability tests for medical devices intended for use in the home setting, in accordance with IEC 62366-1 usability engineering standards.

Our scope of services includes:

• Preparation of the Usability Test Report

• Identification and Recruitment of Suitable Users

• Conducting the usability test in the relevant or representative usage context

• Analysis and Documentation of the Results

• Preparation of a test report that can be used for regulatory purposes for the technical documentation or the Usability Engineering File

We pay special attention to real-world usage scenarios at home and the varying needs of users.