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...
Reimbursement of software in the GKV medical aids directory (HMV)
Healthcare software manufacturers in Germany face a key challenge: How can digital solutions be used to generate revenue in the healthcare system? The market for privately paid products is small, and patients are often reluctant to pay for software out of their own...
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...
Artificial intelligence (AI) in medical devices – MDR guide (2026)
With ChatGPT at the latest, artificial intelligence (AI) has become the topic of our time – also in the field of software medical devices. Many manufacturers are unsure about the extent to which AI can be used in medical devices at all. For this reason, in this...
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