DiGA: Guidelines for demonstrating positive supply effects
What is the point of a DiGA if it does not improve patients’ lives? There is none! This is why DiGAs are only justified when their positive supply effect has been proven. Only then do you have a chance of being permanently included in the BfArM register....
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 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...
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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