IFU Design & Testing

Clearly worded and properly structured Instructions for Use (IFUs) are essential to reduce potentially dangerous usage errors and are an important part of any medical device or IVD. Accordingly, they are subject to strict regulatory requirements.

We help you design your IFUs to meet the requirements of your target markets. To generate the evidence for the testing authorities, we test your IFUs with real users of the target group and provide you with the right documentation right away. You can find out how we do this on this page.

01

Kick-off

First, we get to know you and your product, set a schedule for the joint project and clarify the expectations of both sides in detail. In this way, we ensure that the project runs exactly according to your wishes and ideas.

A customer presents his product to us on a tablet.

02

Presentation and provision of the product

Here we build a deeper understanding of your product and learn which use errors you have already identified. From this, we derive the content of your IFUs and propose a layout.

03

IFU Design

This is where the actual IFU design begins. Of course, we are happy to take your style guides and design specifications into account or develop them together with you. Our design always complies with the regulatory requirements of all target markets.

A user in a UX lab uses the medical device and associated IFUs in a user test.

04

Testing of the IFU with real users

In this step, we observe real users using your product with the help of the designed IFUs. In this way, we find out early on what problems users have with the IFUs so that we can then fix them.

05

Revision, if necessary

If necessary, we adjust the design of the IFUs, ensuring risk-free use and a very good user experience. All this happens in coordination with you.

An employee sits in front of two screens and revises an IFU design.

An employee sits in front of a screen on which a style guide can be seen.

06

Finalization and handover

You will receive the final IFUs in German and English. In addition, you will receive a library of the individual design elements (such as icons) and patterns to create your own IFU designs more efficiently in the future.