The Digital Act (DigiG): Guide for DiGA manufacturers
The new Digital Act of the Federal Ministry of Health was passed on February 2, 2024. It touches on a wide range of topics relating to modern healthcare, such as the electronic patient file (ePA) and regulations on the telematics infrastructure. With regard to DiGA,...
Validation of medical device software according to MDR
If you are developing software that qualifies as a medical device under the Medical Device Regulation (MDR), validation is one of the most critical issues. Successful validation of your software is an absolute prerequisite for bringing your medical device to market....
Interoperability in medicine: Explained using simple examples
A wide range of electronic devices are used in medicine, and medical apps are now also becoming increasingly common. However, a major problem to this day is that many of these devices cannot “talk” to each other: exchanging data is often difficult or impossible. In...
Digital Care Act (DVG): Specification of Digital Health Applications (DiGA)
The Digital Care Act for “better care through digitization and innovation” came into force on December 19, 2019. The aim of the Digital Care Act (DVG) is to enable patients to have health applications prescribed by their doctor, make telemedicine more accessible, and...
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