Approving software medical devices without quality management and regulatory requirements?
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...
Is your app a DiGA? Definition of a digital health app
So-called DiGA (digital health applications) can be reimbursed by statutory health insurance companies. This became possible for the first time when the Digital Supply Act (DVG) came into force on December 19, 2019. However, not every health app or medical app meets...
12 tips for the approval of DiGA in 2024
The implementation of a digital health application (DiGA) involves effort and costs that should ultimately be worthwhile for your company. And indeed – many certified DiGAs that make it onto the market show extremely positive prescription and sales figures....
DiGAV and DVG: Important Links
Here you will find the most important links to the Digital Healthcare Act (DVG) and the Digital Health Applications Ordinance (DiGAV). This list is intended to help you access the relevant documents more quickly for regular reference. This page also provides an...
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