Founded in 1994 we belonged to the first Notified Bodies, which were recognized under the European Medical Device Directive 93/42/EEC and could start to offer services in the area of CE marking of medical devices. From the beginning we have performed audits and certifications of quality systems according to international standards for quality systems.
Since that time we have expanded our range of services without leaving the original sector of medical devices, healthcare and related areas. Besides the continuous extension of our services the merger with the Notified Body „Zertifizierungsstelle Medizinprodukte von ZDH-ZERT e. V.” was a milestone in our history. This was an important basis for the growth of our company which we have reached during the last years. Important steps were also the foundation of our subsidiaries in Berlin in 2010 and Vienna in 2016, as well as the opening of our branch in Tuttlingen. In 2022, our first non-European branch was additionally ceremoniously opened in Haifa, Israel.
Significant milestones were also the designation according to MDR in 2020 as well as the designation according to IVDR in 2023.