Usability Testing for Corona Self-Tests
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...
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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...
On May 26th 2021, the Medical Device Regulation (MDR) will become fully effective. With the entry into force, manufacturers are confronted with numerous challenges, which must be solved in advance, so that the future marketing of products is not delayed. The article lists what medical device manufacturers must pay particular attention to and outlines what has changed in the various areas of requirements and what has been newly added.
What exactly is the IEC TR 62366-2? That is the basic question of this article. We have prepared all the contents for you in a compact and easy-to-understand way. When you have read this article,...