Built to German DiGA standards: what that means

In Germany, digital health applications (DiGA) must meet strict requirements: medical device law, data protection, information security and proof of a benefit for patient care. Our software is built to these standards. The products we rebuild for your country are medical devices in their own right.

• TR-03185

  Certified development process

  Germany's Federal Office for Information Security (BSI) has certified our software development process for digital health applications against TR-03185 (Secure Software Lifecycle). Certificate BSI-K-TR-0900-2026, valid until July 2029, publicly listed in the BSI register.

• TR-03161

  Security tested per application

  Applications we have developed have repeatedly been certified against the BSI technical guideline TR-03161 (security requirements for healthcare applications). The BSI certifies each application individually.

• EU MDR

  Medical device law

  We develop under the European Medical Device Regulation (MDR). Approval or registration follows the rules of your country.

• GDPR

  Data protection

  We work under the EU General Data Protection Regulation (GDPR), plus the requirements of your country.

We work with your authorities to establish which approval and which evidence your country requires.