What is „User Experience“ in the medical sector?
What does the term “user experience” mean? What is the concept behind it? Why is it so relevant for the medical sector? What does the user experience encompass? Why is it so important for your...
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What does the term “user experience” mean? What is the concept behind it? Why is it so relevant for the medical sector? What does the user experience encompass? Why is it so important for your...
The MDR aims (among other things) to guarantee safe and innovative medical devices. In order to ensure safe use, some requirements are placed on the usability of your product. These can be found mainly in the “General Safety and Performance Requirements” (Annex 1 of the MDR). Since Annex 1 applies to all medical devices, you are obliged to address usability for compliance with the requirements made there.
In this article, we answer the following questions: Why does it make sense for the two processes to be intertwined? What is the goal of risk management according to ISO 14791? What is the goal of...