Guide: Is your software a medical device?
That a pacemaker should be a regulated medical device is obvious. However, with software, especially apps, the ambiguity is greater. Software must also be classified as a regulated medical device under the Medical Device Regulation (MDR) if it is used for specific...
Innovation Fund: Funding for digital health solutions
Many manufacturers of medical software and health apps are faced with the question: How can digital solutions be used to build a sustainable business model? The market for self-paying patients in the German healthcare system is relatively small, and the path to...
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...
Approving software medical devices without quality management and regulatory requirements?
The Medical Device Regulation (MDR) poses many challenges for manufacturers of software medical devices. In addition to establishing a quality management system (QMS) and preparing technical documentation, manufacturers face regulatory liability risks. For many...
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