Usability tests for medical devices in accordance with IEC 62366-1

Practical testing of usability in a home environment.

We recruit users according to the intended user groups and product-specific requirements.

We support companies in planning and conducting usability tests for medical devices intended for home use as part of usability engineering in accordance with IEC 62366-1.

Our scope of services includes:

• Preparation of the usability test protocol

• Definition and recruitment of suitable users

• Conducting the usability test in the relevant or representative context of use

• Evaluation and documentation of the results

• Preparation of a regulatorily compliant test report for the technical documentation or the usability engineering file

We pay special attention to the real-world application situation at home and the diverse backgrounds of the users.