Cyber Resilience Act (CRA) for MDR Medical Devices: Implications
It is 2026 and everyone is talking about the Cyber Resilience Act (CRA). The Cyber Resilience Act is new and it is big. Digital products have to meet strict cyber security obligations: report vulnerabilities, deliver updates, and do so across the entire product...
IEC 62304: Software life cycle processes for medical devices
IEC 62304 specifies processes and activities that you must observe when developing software as a medical device. It sets out specific requirements for how you must develop and maintain your software. This applies both to standalone software (e.g., medical apps) and to...
13 Tips for DiGA Approval in 2026
Implementing a digital health application (DiGA) involves effort and costs that should ultimately pay off for your company. And indeed, many certified DiGA that make it onto the market show extremely positive prescription and sales figures. Others, however, do not...
Draft Amendment to the MDR (2025): Implications for Class I Software
In the currently valid version of the Medical Device Regulation (MDR), there is considerable room for interpretation when it comes to classifying software medical devices. In particular, the distinction between risk classes I and IIa is vaguely worded. Manufacturers,...
Sprechen Sie mit unserem Geschäftsführer Malte Bucksch