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We design award-winning.
We test with users internationally.

We develop release ready.

We document ready for approval.

Are you a manufacturer of medical devices or IVDs? Are you looking for support in user interface design, usability engineering and testing or documentation? Then you have come to the right place with us, the Medical Data Driven UX Design agency Custom Medical.

With sister companies in Darmstadt (Germany/EU) and Boston (USA), we at Custom Medical operate on an international scale – from initial design to market-ready development, including global usability and user testing.
Our work has received numerous awards: We are multiple-time winners of the Red Dot Design Award and the German Design Award.

Thanks to our ISO 13485- and ISO 27001-certified processes, we meet the highest standards for medical devices, IVDs, and digital health solutions. We help you bring your products to market in compliance with MDR and FDA regulations – with a strong UX and usability in accordance with IEC 62366-1 that makes all the difference.

We are pleased that you want to get to know us. Let’s find out together if we are the right Data Driven UX Design agency for you. We look forward to meeting you.

What we do

We accompany you in all steps of usability and human factors engineering and help you with formative and summative usability evaluations, user interface design, proper documentation and IFU design.

Here you will learn step by step how we approach these services. We will show you how we help, what a joint collaboration looks like and what results you will hold in your hands in the end.

This picture shows a Custom Medical employee from behind. He is sitting at the computer.
Here you can see two Custom Medical employees in conversation.

How we work at Custom Medical

At Custom Medical, we put real user data at the center of our design decisions. We always keep the regulatory requirements of specific markets in mind. How exactly do we do that? With our Data Driven UX Design process (3DUX® for short)!

Get to know this process step by step. Find out why it leads to a product that is safe, easy to use, and completely delightful for the intended users.

Find out what experiences our customers have had with the 3DUX® process by clicking on “References”.

About our team

Meet our award-winning team. We want to show you who we are and the values that are at the heart of everything we do at Custom Medical.

You are a UX Designer, Documentation Specialist or User Researcher and want to become part of our team? We look forward to receiving your application documents.

The Custom Medical team cheers and celebrates winning the 2022 Red Dot Design Award.
The picture shows our Medical UX Lab. Three employees are standing around an operating table in the usability and UX lab testing a medical device.

Learn more about Medical Usability

We regularly write articles on the topics of medical usability, regulatory requirements in the medical field, usability engineering, user experience, user interface design and user research. We distinguish between medical devices and IVDs.

If you want to inform yourself and need pragmatic support around the above mentioned topics, you are at the right place.

Let’s get to know each other

Are you interested in fast, targeted, and pragmatic collaboration? We want to get to know you and your project. Get in touch and we will work out together how we can support you. Arrange your first free, no-obligation introductory meeting now.