Certification

Testing services for medical devices

We support you in achieving your goal – as a certification body and notified body.

Berlin Cert has been testing and auditing organisations in the field of medical technology since 1997. In this way, we help to ensure that European requirements for safe and effective medical devices are met – from Berlin for customers worldwide.

Berlin Cert is designated for EU Regulation 2017/745 (‘MDR’) (CE 0633) and is monitored by the Central Authority of the German Federal States for Health Protection (ZLG). We have been accredited by DAkkS for EN ISO 13485 since 2007.

Medical Devices

EN ISO 13485

With an EN ISO 13485 certification, you meet international requirements in the field of medical devices. Our experienced auditors comprehensively check how quality is actually practiced at your company - for a reliable and ever-improving quality management system.
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Conformity assessment under MDR

The Medical Device Regulation (Regulation (EU) 2017/745) defines strict requirements for the conformity assessment of medical devices in the EU. Our experts will guide you through the entire process and support your compliant market access with structured assessment procedures - reliably and efficiently.
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MDSAP

We also audit according to the internationally relevant MDSAP standard - via our partner DQS. The audits always take place in combination, as if from a one-stop shop.
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Further management systems

In addition to EN ISO 13485, we offer further combined certifications, e.g. according to ISO 9001, ISO/IEC 27001, ISO 14001, and ISO 50001, together with our parent company GUTcert.
“We have come to greatly appreciate the excellent cooperation, characterized by the prompt and extremely cooperative handling of queries and open issues, as well as the offer of free information sessions, as real added value.”

André Farysch, INMATEC

“The collaboration with Berlin Cert is working perfectly. We have successfully obtained our MDR and EN ISO 13485 certificates. Thank you very much for the trusting and constructive cooperation.”

Oliver Piepenstock (Weiss), Noah Labs

"We appreciate the excellent cooperation with Berlin Cert. In particular, finding pragmatic solutions and clear guidelines are a real added value for us.

Dr.-Ing. Marian Gransow, VIVE-MedTech GmbH

“We greatly appreciate the availability and clear communication about progress.”

Christian Carloni, Trust Care Carloni design AB

Do you have questions? We have answers.
Frequently asked questions
Your contact person
Tanja Hellmeister
+49 30 5858216 - 0