All European Notified Bodies for medical devices lost their designation when MDR and IVDR came into force due to the change in the legal framework and therefore had to or have to be renamed. Not all bodies can or want to overcome these difficulties. Recently, at least one other German Notified Body has decided to stop playing on the MDR field. The German ecm Certification Body for Medical Devices in Europe mbH.
Directly affected by this withdrawal, we have decided to change to DQS. With DQS, we will have an internationally recognized partner with extensive medical device expertise at our disposal in the future, who also offers a wide range of services in the field of management system auditing and product approval via the DQS-UL network.
Especially in these extraordinary times it was a challenge for us to make this change, the more we are pleased to be able to provide the new certificate as of today. This change should show our customers that with us they have a competent and reliable partner at their side. If required, the certificates can be downloaded in German and English language. Please use the download center on this website.
At the same time our management system was audited and a corresponding certificate according to DIN EN ISO 13485 – 2016-08 was awarded. This certificate is also available for download.