Quality management & ISO certification
As a manufacturer of diagnostic medical products and test systems for safety authorities all over the world, we’re committed to optimizing quality. This includes the validation of rapid screening tests.
Our comprehensive quality assurance system includes the following components:
- Validation of all rapid screening tests
- Stability monitoring
- Single lot inspection
- In-process controls
- Monitoring of critical feedstock
- Climate-controlled labs
- Risk management
We are DIN EN ISO 13485 certified since 2004 and ensure compliance for processes and the validation of rapid screening tests.