MDR Risk Class I vs. IIa: Differences for software medical devices
At the beginning of the development of a software medical device, the central question is: Which risk class applies to my product? Risk classification has serious implications and significantly influences the cost and time frame of product development. In extreme...
Class I Software according to MDR – is that still possible? (October 2024)
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 Are risk class I software products really being withdrawn from the market by regulatory authorities?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...
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...
Data security & data protection certificates for DiGA
Digital health applications (DiGA) require certificates for data security and data protection. Following repeated problems with the handling of personal data in some DiGAs in the past, manufacturers will have to have their applications checked more closely in future...
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