All insights: Development and approval of software medical devices in 2025
Over the past ten years, we have learned a great deal about the development of software medical devices. We are pleased to share this expertise in our technical articles with (prospective) developers of Software as a Medical Device (SaMD) so that not everyone has to...
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...
DiPA Guide: Digital Care Apps
On December 19, 2019, the Digital Supply Act (DVG) made it possible for doctors to be able to prescribe digital health applications (DiGA) to patients in a standardized way for the first time. Now a counterpart has also been created for nursing care: digital care apps...
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....
DiGA pricing & 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...
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