Custom Medical services

Even though usability engineering has been common practice in other industries for a long time, the question keeps coming up: do I have to do usability engineering as a medical device manufacturer, or is it voluntary.

This is the performance measure for the product and the official proof that the product is safe to use. This requires that acceptance criteria (What must the product be able to do? How safe must it be?) be jointly defined by you as the manufacturer and us, and tested in the test with the users themselves.

In the MDR, the word usability or usability in the German form occurs only twice. However, there are requirements on the subject of usability in many different places in the guideline. At at least 10 places requirements are made to the product and the manufacturer, which can be fulfilled only with a useful Usability engineering process. 

Whether a product is really good can only be seen when it comes into contact with the subsequent user. The time of the first contact is decisive for the quality of your product.

What’s that all about? And what about user experience? Yes, legally that was “already” all. BUT we love great products. Custom Medical embodies pragmatic usability engineering. For us, this means: we only establish things that really give you and your users an advantage. On the one hand, we accompany you to develop and test your products so that you have all the contents necessary for approval. On the other hand, we want to use every contact with the user as purposefully as possible.