What is the IEC 62366-1?
What exactly is IEC 62366-1? We want to get to the bottom of this question in this article. We will explain to you quickly and in an easy-to-understand manner what there is to know about the...
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What exactly is IEC 62366-1? We want to get to the bottom of this question in this article. We will explain to you quickly and in an easy-to-understand manner what there is to know about the...
With the summative evaluationwhich is the final evaluation, you prove that the interface of your medical device can be used without critical risks. Everything has to be right on this point. You have...
To prove that you meet all MDR requirements regarding usability, you need a complete Usability Engineering File. Under certain circumstances, your product could use the abbreviated UOUP process of IEC 62366-1 for this purpose. If your product does not qualify for this, there is the possibility to argue on the basis of the Post Market Surveillance data of your (or a similar) medical device and to prove with an appropriate rationale that your product does not pose any unacceptable risks by its use. However, the latter may lead to unwanted discussions. A summative usability evaluation is often the safer way to go.
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