News:
- 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:
- 19.01.2024: Innovation Day Berlin Cert / GUTcert: Registration
- 13.-14.03.2024:Auditor Day GUTcert / Berlin Cert
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.