Services of the Certification body/Notified Body

Certification of QMS according to DIN EN ISO 13485 and Conformity Assessment procedures according to MDR

We have been testing and auditing medical technology companies since 1997. In this way, we play our part in ensuring that the European requirements for safe and effective medical devices are met. Our extensive expertise in this area sets us apart and ensures satisfied customers, patients and users.

We are a designated company for EU Regulation 2017/745 (‘MDR’) and are monitored by the Central Authority of the Länder for Health Protection (ZLG). We have been accredited for DIN EN ISO 13485 by the DAkkS since 2007.

A company that has been positively audited by Berlin Cert in accordance with EU Regulation 2017/745 receives a corresponding certificate and is therefore authorised to affix the CE mark to its products and sell them in Europe.

The basis for a conformity assessment in accordance with MDR is a functioning quality management system in accordance with DIN EN ISO 13485. We also offer certification in accordance with this quality management standard in combination with an MDR procedure.

If you are also interested in certifications for other areas (energy/environmental management, occupational safety, etc.), please contact our parent company GUTcert directly.