How to Complete the User Needs Section of User Interface Requirements

To meet the FDA’s standards for medical devices, you must complete user interface specifications or requirements. These specifications, according to IEC 62366-1, “comprehensively and prospectively describe the user interface of a medical device.” And a user interface refers to all the ways a user and a device interact.

If you let it, a user interface specification can be so much more than a regulatory box to check. A robust specification establishes design specs, which inform the experience users ultimately have with your product — and overall brand. What’s more, a positive user experience largely dictates the commercial success of your product.

There’s a lot at stake. So how do you properly complete the user needs section of user interface specifications? Our template offers guidance on doing just that, including a blank chart to get started on your own user needs documentation.