Class I Software according to MDR – is that still possible? (December 2025)
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...
Classification of software medical devices: MDR Guideline
“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...
Medical devices and Switzerland: what you need to know about MedDO and MDR
Although Switzerland is geographically located in the heart of the EU, it is not part of it. This also affects manufacturers of (software) medical devices. Is it possible for MDR medical devices to enter the Swiss market without further ado? How do Swiss manufacturers...
ISO 13485 – Guide to requirements and content
Anyone involved in the development of software medical devices is certainly no stranger to the term “Quality management system” (QMS). You may also have heard of ISO 13485 in this context. ISO 13485 is a standard that defines the requirements for a quality...
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