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...
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...
Medical devices in Switzerland: MedDO vs. MDR
Although Switzerland is geographically located in the heart of the EU, it is not part of it. This also affects manufacturers of (software) medical devices. Is it possible for MDR medical devices to enter the Swiss market without further ado? How do Swiss manufacturers...
Validation of medical device software according to MDR
If you are developing software that qualifies as a medical device under the Medical Device Regulation (MDR), validation is one of the most critical issues. Successful validation of your software is an absolute prerequisite for bringing your medical device to market....
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