BSI TR-03161 for DiGA: Data Security Certification
Since January 1, 2025, manufacturers of digital health applications (DiGA) must prove compliance with data security requirements by means of an official certificate. The basis for certification is BSI TR-03161, which was first published in 2020. The BfArM checks...
IVDR Software: Qualification & Classification
Many in vitro diagnostic devices today consist not only of physical test kits, but also of complex software that calculates, interprets, or visualizes analysis results. As a result, more and more software is falling within the scope of the In Vitro Diagnostic...
Guide: Is your software a medical device?
That a pacemaker should be a regulated medical device is obvious. However, with software, especially apps, the ambiguity is greater. Software must also be classified as a regulated medical device under the Medical Device Regulation (MDR) if it is used for specific...
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...
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