Our new ISO 13485:2016 certificate is available!
ISO 13485:2016 certificate
The certificate marks the end of the transition from Lloyds Register to our new Notified Body Dekra Certification GmbH.
This is a major step in our compliance with Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices. The scope of our activities remains unchanged.