Module 14: Design Development and Certification of Medical Devices

What is the Human Factors and Usability Engineering process?

What documentation should be included in a Human Factors and Usability Engineering process?

❑ Use Specification – where the intended users, use environments and use scenarios are defined. ❑ Task Analysis – where the intended tasks and use scenarios are determined. ❑ Usability/Human Factors Risk Assessment – where task-based risks are evaluated and use based risk determined. ❑ User Interfaces / Validation Test Plan – where the user interfaces are defined and their routes for verification and validation are determined. ❑ Formative Usability/Human Factors Studies – where design concepts, user interfaces, software, hardware and the final design of the device are tested with intended users to verify the design. ❑ Summative/Validation/Comparative Usability/Human Factors Study – where production level devices are tested with intended users, in the intended use environment, under typical use conditions to validate the device design meets the user’s needs. ❑ Usability/Human Factors Engineering File – where all the usability and human factors effort is contained.

The Organisation for Professionals in Regulatory Affairs

Human Factors and Usability Testing during development