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Looking for a certification body or notified body?

Berlin Cert’s proposal: personal visit at your stand at the Medica

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EUDAMED - The database in the sense of the MDR

Central electronic database contains information on manufacturers, Notified Bodies, clinical trials, certificates and market surveillance

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Software classification in the sense of Medical Device Regulation (MDR)

Software for the prediction or prognosis of diseases continues to count as a medical product in the sense of MDR.

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Accreditation certificate DIN EN ISO 13485:2016

Our accreditation certificate for DIN EN ISO 13485:2016 is now available in the download area!

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UDI - Unique Device Identification

In Europe, the introduction of the Medical Device Regulation (MDR) will make a UDI system mandatory for all manufacturers of medical devices. The transition period ends on 26.05.2020.

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Important deadlines for MDR conversion at a glance

Time's running out! The Medical Device Regulation (MDR) was published in May 2017 and will replace Directive 93/42/EEC and Directive 90/385/EEC.

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Berlin Cert - Product range expanded

Cooperation in the field of medical technology opens up new perspectives

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Accreditation certificate

Accreditation certificate

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Berlin Cert ist now part of GUTcert

Berlin Cert ist now part of GUTcert

Read more … Berlin Cert ist now part of GUTcert