News:

  • Important information laboratory tests: Discontinuation of accredited laboratory tests
  • Certification in accordance with DIN EN ISO 13485:2021 or EN ISO 13485:2016/A11:2021 - simple and on time: request
  • Clarification of open questions regarding MDR conformity assessment or certification according to (DIN) EN ISO 13485: Free Consultation Hour
  • IT Security: standardized web and mobile penetration tests to secure your (customer) data: Offer

Trade Fairs and Events:

  • 13.-14.03.2024:Auditor Day GUTcert / Berlin Cert

 

Independent testing, certification and conformity assessment


Certification Body | Notified Body

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

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

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


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With GUTcert at our side, we can offer you even more:

All services are also offered in an integrated form, supplemented by a wide range of further training courses.


References

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"We particularly liked the uncomplicated and very quick contact."

- Dr. Laura Sulik, Senior Product Manager, LUORO GmbH -
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- VELA -

"Very pleased with all of the cooperation, dialouge and effort provided by Berlin Cert during this process."

- Runar Simonsen, HEPRO AS -
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"We very appreciate the availability and clear communication in the progress."

- Christian Carloni, Managing Director, Trust Care Carloni design AB-, TRUST CARE -
"Despite the restrictions caused by 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 -
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"Fast processing, good support for questions and problems. Top customer service, top staff."

- Jan Frank, Management / Development, HOGGI - Made in German -
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"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 -
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"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."

- Dr. Dirk Colditz, QMB, PRRC and Head of QM/RA/R&D/IT, MGB Endoskopische Geräte GmbH -
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"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, Otto Bock Mobility Solutions GmbH -