Classification of software medical devices: MDR Guideline
“The use of my app is completely safe. It certainly falls into the lowest risk category.” – MDR probably sees it differently. Anyone who wants to certify their software as a medical device in accordance with the Medical Device Regulation (MDR) must...
Data security & data protection certificates for DiGA
Digital health applications (DiGA) require certificates for data security and data protection. Following repeated problems with the handling of personal data in some DiGAs in the past, manufacturers will have to have their applications checked more closely in future...
AI Act: Guidelines for medical device manufacturers according to MDR (2025)
The EU is now also regulating the use of artificial intelligence (AI) with the EU AI Act. This also affects manufacturers of software medical devices that integrate AI into their MDR medical devices. The AI Act is intended to ensure that AI systems are designed in a...
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...
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