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Is Usability Engineering mandatory for your medical device? Which regulations and standards must be observed? Can you benefit from a possible Usability Obligation and how do you manage to comply with the obligation in the most targeted and uncomplicated way…

  You know that you have to demonstrate Usability Testing for your In Vitro Diagnostic Device (IVD) according to the In Vitro Diagnostic Device Regulation (IVDR), but you don’t know yet how exactly you have to prepare for it? Then…

What exactly is a summative evaluation or summative usability evaluation? How does it differ from a formative evaluation? How does the summative evaluation proceed and what do you have to consider? What exactly is evaluated? If you have asked yourself…

What will change for you as a manufacturer of IVDs when the IVDR comes into effect? Do you have an IVD on the market and don’t know what you need to accomplish when moving to the IVDR? Are you looking…

What is the IVDR? When does it come into effect? Where exactly does the IVDR apply and what are the Usability requirements for your IVD? How do you ensure that these Usability requirements are met in accordance with the IVDR?…

Do you have to do Usability Engineering to get the clearance of your IVD? If so, how can you ensure that it is done in accordance with the regulations? What does the IVDR require regarding the Usability of an IVD?…

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 product and how can you…

If you want to get the clearance for a Corona self-test, you have to ask yourself some important questions. What are the usability requirements for your product? Which standards and regulations do you have to observe? How do you implement…

Poor usability of a medical device can lead to injuries and endanger the well-being of patients or users. For you as a manufacturer, there is also the risk, that your product will not be approved or that you will be…