Berlin Cert GmbH is an independent testing and certification body specialising in the certification of products and quality management systems. Our focus is on manufacturers and suppliers of medical devices, including software products. As a wholly owned subsidiary of GUTcert, we are part of the extensive network of the internationally active AFNOR Group, which gives our customers access to globally recognised standards and expertise.
Our roots go back to 1915, when the testing centre for artificial limbs was founded by the renowned professors Dr Schlesinger and Dr Sauerbruch. This historical foundation not only gives us deep roots in the testing and certification landscape for medical devices, but also many years of expertise that we bring to our services.
With a clear commitment to quality, integrity and customer focus, we offer you a reliable partnership. Whether it's the approval of your latest medical device or the certification of your quality management system, in Berlin Cert GmbH you will find an experienced and competent partner who will support you on your way to market launch.
1915
founded
> 25
Years of experience as an independent certification body
> 30
Auditors and technical experts
0
Tolerance in patient safety
Audits with added value
A willingness to learn is an essential factor for success today. Our audits help organisations to develop potential and minimise risks. We love to ‘surprise’ our customers during on-site audits with newly discovered opportunities. We encourage them to rethink their business processes and thus ensure the long-term success of their company.
As a subsidiary of the internationally active AFNOR Group, we have a network of more than 3,000 auditors. This means you can have audits carried out in over 100 countries worldwide, both through Berlin Cert and the AFNOR Group. If required, we can provide you with a bilingual contact person (German/English) and, on request, an auditor can take on the leading role centrally.
We have returned our testing laboratory accreditation as of 31 August 2024. The certificates under which tests were carried out and reports issued up to August 2024 can be found in the archive.