News:
- Meet us in Munich @ KI MedTech: Speaker Martin Tettke on the "Challenges in the certification of medical devices with AI"
- Meet us in Stuttgart @ MedtecLIVE: With the joint portfolio of Berlin Cert and GUTcert, you receive all tests from a single source
- Meet us online: Clarification of open questions regarding MDR conformity assessment or certification according to (DIN) EN ISO 13485: free consultation hour
- Important information laboratory tests: Discontinuation of accredited laboratory tests
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.