Certification

Kibion provides customers with high quality products and services.

The quality of our processes, products and services are continuously optimized and improved to meet customers’ demands and needs.

Kibion AB is certified based on EN ISO 13485 – Medical Devices – Quality Management Systems – Requirements for regulatory purposes. The scope of the certificate includes development, production and distribution of IVD medical devices. The Certification was carried out by TÜV SÜD Product Service GmbH which is a worldwide recognized Certification Body.

The EN ISO 13485 certification strengthens Kibion AB to further develop its leading position as provider of breath tests for detection of Helicobacter pylori worldwide.

Kibion also complies for Good Distribution Practice according Article 84 of Directive 2001/83/EC and has been inspected in accordance with Art. 77 (1) of Directive 2001/83/EC.