by Alexander Fenkiw | Sep 27, 2025 | medical-software-whitepaper
Are there still Class I software medical devices according to MDR? Are regulatory authorities really withdrawing Class I software products from the market in droves? Which federal state do I need to go to in order to remain on the market with my Class I software? As...
by Alexander Fenkiw | Sep 27, 2025 | medical-software-whitepaper
“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...
by Malte Bucksch | Sep 27, 2025 | medical-software-whitepaper
That a pacemaker should be a regulated medical device is obvious. However, with software, especially apps, the ambiguity is greater. Mobile apps must also be classified as a regulated medical device if they are used for specific purposes such as the diagnosis or...
by Daniel Lange | Jun 13, 2025 | medical-software-whitepaper
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...
by Alexander Fenkiw | Jan 31, 2025 | medical-software-whitepaper
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...
by Malte Bucksch | Jan 8, 2025 | medical-software-whitepaper
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...