DiPA Guide: Digital Care Apps
On December 19, 2019, the Digital Supply Act (DVG) made it possible for doctors to be able to prescribe digital health applications (DiGA) to patients in a standardized way for the first time. Now a counterpart has also been created for nursing care: digital care apps...
AI Act: Guide for medical device manufacturers according to MDR (2024)
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...
Data security & data protection certificates for DiGA
Digital health applications (DiGA) will soon require certificates for data security and data protection. However, the original deadlines for this were set somewhat too optimistically, which is why they have now been postponed to the future by the Hospital Nursing...
Phrasing of the intended use 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...
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