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 markts for more than 22 years now. More

According to the Directive 93/42/EEC, medical devices must carry a CE mark. The CE mark can be placed on the product only when your medical device meets the essential requirements and the required conformity assessment has been carried out. 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 ISO 13485 CMDCAS, PAL for Japan, 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