CE marking
ISO 13485

We certify medical devices and quality management systems. As one of the largest German Notified Bodies, we are active on the international markets since 1994. More

Medical devices may only be placed on the market or put into service in Europe if they bear the CE marking.  More

ISO 13485 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. More

MEDCERT operates internationally and offers, among others, certification services like MDSAP, TCP for Taiwan and GDPMD for Malaysia. With own branches in Europe, Northamerica and Asia we offer medical device manufacturers international presence combined with local competence. More