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The European Commission published the document "MDCG 2019-16 Guidance on Cybersecurity for medical devices" on January 7, 2020
Read more … MDCG 2016-16 on Cybersecurity published
The European Commission submitted the proposal for the 2nd corrigendum to the MDR to the European Parliament, which was published in the Official Journal on 27.12.2019. What this means can be found in this article.
Read more … MDR: Corrigendum 2
Berlin Cert’s proposal: personal visit at your stand at the Medica
Read more … Looking for a certification body or notified body?
Central electronic database contains information on manufacturers, Notified Bodies, clinical trials, certificates and market surveillance
Read more … EUDAMED - The database in the sense of the MDR
Software for the prediction or prognosis of diseases continues to count as a medical product in the sense of MDR.
Read more … Software classification in the sense of Medical Device Regulation (MDR)
Our accreditation certificate for DIN EN ISO 13485:2016 is now available in the download area!
Read more … Accreditation certificate DIN EN ISO 13485:2016
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.
Read more … UDI - Unique Device Identification
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.
Read more … Important deadlines for MDR conversion at a glance
Cooperation in the field of medical technology opens up new perspectives
Read more … Berlin Cert - Product range expanded
Read more … new: ISO 13485 with CMDCAS/MDSAP
Read more … Accreditation certificate
Berlin Cert ist now part of GUTcert
Read more … Berlin Cert ist now part of GUTcert
new certificate of recognition of our testing lab
Read more … new certificate of recognition of our testing lab
Read more … Akkreditierungsurkunde Zertifizierstelle