MDR Risk Class I vs. IIa: Differences for software medical devices
At the beginning of the development of a software medical device, the central question is: Which risk class applies to my product? Risk classification has serious implications and significantly influences the cost and time frame of product development. In extreme...
Phrasing of the intended use for (software) medical devices
How do I actually decide whether my product is a medical device? Where do I start when I want to determine its risk class? And what statements can I use to promote my product in the end? The answers to these and many other questions can be answered on the basis of...
DiGA price negotiations with the GKV-Spitzenverband
The development of a digital health application (DiGA) costs time and money and involves many regulatory hurdles. As a manufacturer, you naturally have an interest in ensuring that this effort pays off in the end. You probably already know that even if your...
Interoperability for digital health applications (DiGA)
We would like to quickly introduce the topic of interoperability in DiGA development with a small example: “Μια DiGA πρέπει να πληροί ορισμένες απαιτήσεις διαλειτουργικότητας.” Do you understand this sentence? Unless you speak Greek, probably not. You therefore need...
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