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You have an already developed medical device that was developed without usability engineering and would now like to know what options you have to still meet all the usability requirements of the Medical Device Regulation (MDR)? That is the core…

What are the requirements for your medical device to use the User Interface of Unknown Provenance process? What are the different cases in which the process can be used? We clarify these questions in our article. In addition, we have…

What is a User Interface of Unknown Provenance? And what exactly is the User Interface of Unknown Provenance process (UOUP for short)? When are you authorized to use this process? What does this process look like in detail? We answer…

Are you a medical device manufacturer and have to meet usability requirements for your medical device since the introduction of the MDR? Are you wondering why this is the case? You want to know what exactly has changed and what…

You are established as a manufacturer of medical devices and are now wondering why you suddenly have to meet some Usability requirements for your product with the introduction of the Medical Device Regulation? What exactly has changed? Where can you…

What is the MDR? When did it come into force? Where exactly does the MDR apply and what are the Usability requirements for your medical device? How do you ensure that these Usability requirements are also compliant with the MDR?…

How exactly does the Usability Engineering process work? What does IEC 62366-1 require of you? What exactly do you have to prove? In this article, we clarify exactly these questions and take a step-by-step look at the Usability Engineering process.…

What exactly is a formative Usability Evaluation? Is it mandatory? How is it different from a summative Evaluation? How can your product benefit from one (or more) formative Evaluation(s)? What is the best possible approach for formative Evaluations and which…

You could not attend the MedTec Summit this year and missed the lecture “Efficient and safe – IVD-R compliant through Usability Engineering”? Our Lead User Experience Researcher Medical Dr. Jonas Walter has recorded this exact lecture for you. The lecture…