Quality management

Our products meet the legal and regulatory requirements for medical devices and are CE certified according to the Medical Devices Directive 93/42 / EEC of the European Parliament and of the Council. In addition, the GILUPI CellCollector® Detector CANCER01 has been approved and certified by the China Food and Drug Administration (CFDA).

In order to ensure the quality of our products and to constantly improve them, we have a TÜV certified quality management system. In addition, our QM system is constantly checked for constant improvement and compliance with laws and standards. We are certified according to DIN EN ISO 13485.

 

Certificates