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...
by Alexander Fenkiw | Oct 18, 2024 | medical-software-whitepaper
Are there still software medical devices in risk class I according to MDR? Are risk class I software products really being withdrawn from the market by regulatory authorities? Which federal state do I have to go to so that I can remain on the market with my class I...
by Alexander Fenkiw | Sep 10, 2024 | medical-software-whitepaper
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...
by Alexander Fenkiw | Sep 10, 2024 | 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 deal...