News:
- Ask us @Medical Device Days - Johner Institut: 08.10.2024-09.10.2024, Berlin. Notified-Body-Consultation Hour
- Meet us @Cyber Security in Medical Technology - HLMC Events GmbH: 15.10.2024-16.10.2024, Munich. Presentation: "Conformity Assessment of SaMD - what role does Cyber Security play and what to look out for?"
- Meet us @MEDICA 2024: More information to follow
- Meet us @BVMed: 14.11.2024, 09:00-16:00, Frankfurt am Main, Special Event. Topic: "Medical device law in practical implementation".
- Join us @GUTcert, Innovation Day Certification, on 17.01.2025. Further information will follow.
- Meet us online: Clarification of open questions regarding MDR conformity assessment or certification according to (DIN) EN ISO 13485: free consultation hour
Independent Testing, Certification and Conformity Assessment
Certification Body | Notified Body
As experts for medical devices, we are your reliable partner for ISO 13485 system certification, MDR conformity assessment & DiGAs / SaMD.
Neutral, confidential and transparent.
IT-Security
IT-Security is a must for every company. With our penetration tests and ISMS certifications, you can ensure, that your IT-Infrastructure is optimally protected. Relly on our Expertise and protect your Data.
Further certifications
With GUTcert at our side, we also offer:
References
"I am very satisfied with the work and professionalism of Berlin Cert. [...] I got very good [useful] feedback from Berlin Cert."
"The cooperation is excellent, queries and open points are dealt with promptly. The clarity of the [...] test report format is excellent. "
"Very pleased with all of the cooperation, dialouge and effort provided by Berlin Cert during this process."
"We particularly liked the uncomplicated and very quick contact."
"Fast processing, good support for questions and problems. Top customer service, top staff."
"We very appreciate the availability and clear communication in the progress."
"For many years, Berlin Cert has been the certification body for our company and its predecessors for the quality management system in accordance with DIN EN ISO 13485, as well as the notified body for the conformity assessment procedures for our medical devices. We value the cooperation in particular because of the critical, fair and always trend-setting assessments. Particularly in difficult business situations, Berlin Cert has not lost sight of us and has supported us with continuity and responsiveness. We are certain that the cooperation with Berlin Cert will continue to be of great benefit to us as an international company."