Quality StandardsCompliance with the highest quality standards
// constant improvement
// high quality products
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.
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.
With this, the qualification for the manufacture of medical devices (IVDD) was officially confirmed. Certification according to IVDR is currently being planned. The effectiveness and maintenance of the quality assurance measures and our quality standards are certified at regular intervals by external testing institutions.
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.