12 tips for the approval of DiGA in 2024
The implementation of a digital health application (DiGA) involves effort and costs that should ultimately be worthwhile for your company. And indeed – many certified DiGAs that make it onto the market show extremely positive prescription and sales figures....
Guide: Is your app a medical device?
That a pacemaker should be a regulated medical device is obvious. However, with software, especially apps, the ambiguity is greater. Mobile apps must also be classified as a regulated medical device if they are used for specific purposes such as the diagnosis or...
DiGAV and DVG: important links
Here you will find the most important links to the Digital Healthcare Act (DVG) and the Digital Health Applications Ordinance (DiGAV). This list is intended to help you access the relevant documents more quickly for regular reference. This page also provides an...
Artificial intelligence (AI) in medical devices – MDR guide (2024)
With ChatGPT at the latest, artificial intelligence (AI) has become the topic of our time – also in the field of software medical devices. Many manufacturers are unsure about the extent to which AI can be used in medical devices at all. For this reason, in this...
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