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.

Test laboratory
We test the safety of your medical devices and aids. Our accredited laboratory for mechanical and electrical tests, microclimate and mattress tests looks forward to your enquiry - also for individual test procedures.

Other management systems
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. Rely on our expertise and protect your data.
Further certifications

With GUTcert at our side, we can offer you even more:
- managementsystems according to ISO standards
- renewable energies
- carbon footprint
- sustainability
All services are also offered in an integrated form, supplemented by a wide range of further training courses.
References
"The cooperation is excellent, queries and open points are dealt with promptly. The clarity of the [...] test report format is excellent."
- Matthias Bock, Leiter Testing bei Otto Bock Mobility Solutions GmbH -
"Despite the restrictions due to the Corona pandemic, the handling of our audit assignment went smoothly. We are always pleased about the pleasant cooperation with Berlin Cert. Many thanks for that!"
"As always with Berlin Cert: great and smooth service. :-)"
- Kurt Schröder, CEO G&S Medizintechnik -
"I am very satisfied with the work and professionalism of Berlin Cert. [...] I got very good [useful] feedback from Berlin Cert."
- Christophe Lecomte, Director of Biomechanical Solutions, Össur -
"Fast processing, good support with questions and problems. Top customer service, top staff."
- Jan Frank, Geschäftsführung / Entwicklung, HOGGI GmbH -
"We very appreciate the availability and clear communication in the progress."
- Christian Carloni, Managing Director, Trust Care Carloni design AB-
"We particularly liked the uncomplicated and very quick contact."
- Dr. Laura Sulik, Senior Produktmanagerin, LUORO GmbH -
"Very pleased with all of the cooperation, dialouge and effort provided by Berlin Cert during this process."
- Runar Simonsen, HEPRO AS -