Quality Standards

Compliance with the highest quality standards

// constant improvement

// high quality products

Quality Management

Since its foundation, CONGEN Biotechnologie GmbH has been working to the highest internal and external standards of quality. Our customers and partners benefit from quality-assured processes and high-quality products. These are subject to constant monitoring and are continuously optimised on the basis of customer requirements, scientific developments and legal requirements.

As part of our quality assurance with a process-oriented and risk-based approach, all processes, from the delivery of raw materials to the sale of the product, are controlled and traceability is guaranteed.


With certification (2001) and regular recertification of our quality management system according to DIN ISO 9001, the maintenance of our quality standard and the consistent reliability of our kits is confirmed.​

Medical Devices

In addition to the certification of the applied quality management system, in accordance with the requirements of DIN EN ISO 9001, CONGEN Biotechnologie GmbH received certification in accordance with DIN EN ISO 13485, building on its many years of experience.

The effectiveness and maintenance of the quality assurance measures and our quality standards are certified at regular intervals by external testing institutions.


With the certification according to DIN EN ISO 13485 in 2013, it was confirmed that CONGEN fulfils the quality requirements for manufacturers of medical devices and is thus allowed to produce CE-marked products that are recognised worldwide.​

External Validation

In addition to certifications in the area of the quality management system, selected products are validated by external providers. In 2008, the first detection method, as an alternative method in the microbiological field, was validated by AOAC International and Microval. This confirmed the comparability to standard microbiological methods.

All certificates mentioned here can be viewed and downloaded in the currently valid version at any time under the respective item. Further procedures for external validation are being planned.