Module 14: Design Development and Certification of Medical Devices

Evaluating medical devices in Human Factors and Usability Studies

Commonly, medical devices are either studied or tested. Formative Usability Studies focus on user interfaces, design and development of these user interfaces.

Summative Usability Studies focus on performance of the intended users with the device.

The focus is to ensure that the intended users can use the device in the intended manner, in the intended use environment using the intended user interfaces. Medical devices now include more than just a device – apps, software, integration with other devices, packaging, smart-instructions etc.

Evaluation of medical devices must focus on the system – all components including software and all user interfaces.

The Organisation for Professionals in Regulatory Affairs

Human Factors and Usability Testing during development