QuickBird Medical has received two new certificates from the BSI under Technical Guideline TR-03161 for DiGA projects within a single week. Both certifications were passed without conditions.
This brings the number of DiGA projects for which QuickBird Medical has obtained a BSI certificate to four. An overview of the two new certificates:
- Third certificate for the product Alvie, which QuickBird Medical developed on behalf of Anker Health. It is already the third DiGA project that both companies have successfully taken through certification together. TÜV TRUST IT (TÜV AUSTRIA Group) acted as the assessment body for the procedure.
- Fourth certificate for a prospective DiGA in the field of dermatology. Here PwC Germany took on the role of the assessment body.
In both projects, QuickBird Medical was responsible for IEC 62304-compliant product development, the implementation of the technical requirements of the DiGAV and the BSI certification under TR-03161.
Technical Guideline TR-03161 defines the security requirements for applications in healthcare. Meeting it is a key prerequisite for a digital health application to be listed in the BfArM’s DiGA directory. That both procedures were completed without conditions confirms the regulatory and technical maturity of the products developed.
Announcement of the certifications by QuickBird Medical: Alvie certificate & dermatology certificate
Within one week, QuickBird Medical receives two further BSI certifications
Would you like to learn more about QuickBird Medical’s previous BSI certifications?