As a medical product company we need a quality management system certified according to EN ISO 13485:2012. We are audited by out Notified Body regularely.
This year a re-certification audit was scheduled in June. We prove our quality management system to be valid and can now present our new certificates.
Beside the special standard for medical products our quality management system is certified according to ISO 9001:2008, too.
The documents can be downloaded from this website.
Our certificate status can be checked on www.certipedia.com as well.
