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Knowledge about Medical Usability and UX

In order to pragmatically and efficiently improve the usability and UX of one’s own medical device or IVD and meet all regulatory requirements, expertise and an overview of the most important methods and best practices around medical usability and UX are needed.

That’s exactly what we want to offer you in our technical articles. From our easy-to-understand basic terms to the in-depth Deep Dive article, valuable knowledge can be found here for all levels of experience. Quick answers to frequently asked questions are provided in our FAQs.

Frequently asked questions about Medical Usability

What is required of you in the area of usability?

The MDR rarely mentions the usability of medical devices, but does require some points from you regarding usability that must be met. The same is true for the IVDR and IVDs. Both require a complete usability engineering file from you.

Find out the requirements of the MDR here.

Find out the requirements of the IVDR here.

The FDA requires that you address the usability of your medical device if a serious hazard may result from the use of the device or if the device appears on the “List of Highest Priority Devices for Human Factors Review.”

Learn more here.

How much Human Factors do I need to do if I already have an existing product that I'm just updating?

Of course, this depends on the particular market in which your product is to be approved. However, the goal is always a complete usability engineering file or a complete human factors report. For your existing medical device or IVD, the following options are available so that you do not have to start from scratch:

  • Your product can go through the abbreviated User Interface of Unknown Provenance process of IEC 62366-1
  • You can argue with post market surveillance data and create a rationale
  • You can argue with summative usability evaluations or the PMS data of comparable products

Learn more here.

What is the best way to integrate human factors into development?

FDA, MDR and IVDR require some points concerning the usability of your medical device or IVD, but without clear statements on how exactly you have to implement them.

For the implementation of the MDR and IVDR requirements, we believe that the usability engineering process according to IEC 62366-1 is the most pragmatic and safest way.

You can learn more here.

The FDA offers good suggestions for the implementation of medical usability in a guidance document entitled “Applying Human Factors and Usability Engineering to Medical Devices“.

What does my study need to look like to work for the FDA?

The FDA divides medical devices into three risk classes. Depending on the class, the requirements may change.

The following points are usually required by the FDA:

  • The designation of critical use steps, which are to be found out by a risk analysis
  • An exclusion of use-related hazards
  • A validation of the Human Factors measures by Human Factors Validation Testing/ a summative evaluation.
Do I really need to do a study for Human Factors?

If your product is Class 2, then you need to formulate a intended purpose and identify known use problems. For this, you should make Human Factors.

If you have a product in risk class 3, then the documentation of formative evaluations, a risk analysis of all usability-related risk scenarios, and a final validation are added to the above points.

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