Phrasing of the intended purpose 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...
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...
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....
Guide to §374a SGB V – Interoperability for DiGA, aids & implants
Attention manufacturers of electronic aids, implants and DiGA! From mid-2024, a new legal requirement will apply to improve interoperability between medical devices and digital health applications (DiGA) approved by the BfArM: §374a SGB V Specifically, this involves...
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