Certification body / Notified body
Certification according to EN ISO 13485 and conformity assessment according to MDR
We have been inspecting and auditing medical technology companies since 1997. In this way, we help to ensure that the European requirements for safe and effective medical devices are met. Our extensive expertise in this area characterises us and ensures satisfied customers, patients and users.
ISO 13485 Certification
With EN ISO 13485 certification, you fulfil international requirements for quality management systems in the field of medical devices.
Our certification is more than just a document check: our experienced auditors comprehensively check how your quality management system is actually implemented - precisely, neutrally and transparently.
Conformity assessment according to MDR
The Medical Device Regulation (MDR) defines strict requirements for the conformity assessment of medical devices in the EU. Our experts will guide you through the entire process and support your compliant market access with structured assessment procedures - reliably, efficiently and in accordance with standards.
Product certification (MDR)
You can achieve CE labelling for individual products via product certification. It is worth considering this route, especially for particularly small quantities or an early product launch for a valid assessment of market relevance.
Other certifications
We offer further certifications, also in combination (e.g. according to ISO 9001, ISO / IEC 27001, ISO 14001, ISO 50001) via our parent company GUTcert, certifications according to MDSAP with our partner DQS.
We are designated as a company for EU Regulation 2017/745 (‘MDR’) and are monitored by the Central Authority of the Federal States for Health Protection (ZLG). We have been accredited for DIN EN ISO 13485 by the DAkkS since 2007.