Kibion AB is now EN ISO 13485 Certified.
Kibion AB is now certified based on EN ISO 13485: 2003 / AC: 2009 – 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 strengthen Kibion AB to further develop its leading position as provider of breath tests for detection of helicobacter pylori worldwide.