QuickBird Medical has successfully obtained BSI TR-03161 certification for another digital health application (DiGA). This makes it the second DiGA project by the company to be certified against the demanding security guideline of the German Federal Office for Information Security (BSI).
The TR-03161 guideline is a mandatory security requirement for DiGA manufacturers and is considered one of the biggest regulatory challenges in the German digital health market. The certification process involves extensive technical, organisational and procedural requirements and often stretches over several months.
The path to certification is and remains demanding. Implementing TR-03161 requires far-reaching changes to the architecture, processes and user journey of a DiGA. These challenges currently affect many manufacturers in the market and remain the subject of intense discussion within the industry.
Alongside the two projects already certified, further DiGA that QuickBird Medical is developing together with its customers are currently going through the certification process.
Announcement of the certification by QuickBird Medical: Click here
QuickBird Medical receives its second BSI TR-03161 certification for a DiGA project.