MedtecLIVE

My Account

Language

Logo Berlin Cert GmbH

Berlin Cert GmbH

Short description

Certification of QMS in accordance with DIN EN ISO 13485 and conformity assessment procedures in accordance with MDR We have been inspecting 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 d

from Berlin, Germany

Contact

Followers

Anastasia Simon
M
C
B
4 Following
Show all

Posts (1)

Description

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 characterises us 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 Federal States 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.

Location

Berlin Cert GmbH

Berlin, Germany
Dovestraße 6

Representation

Frittlingen, Germany
Daimlerstraße 25

Contact

Prof. Dr. Jan Uwe Lieback

Prof. Dr. Jan Uwe Lieback

CEO
Write message
Johannes Lieback

Johannes Lieback

CEO
Write message
Andreas Lange

Andreas Lange

Auditor and technical expert
Write message
Heiko Leppin

Heiko Leppin

IT-security expert
Write message