Certificates

We did it! in July 2023 we received the MDR certification according to the EU Medical Device Regulation 2017/745 from our notified body.
This certification covers as a first step our medical devices of class IIb cylinder pressure regulators. We will use the transition period of the MDD depending on the product category. However, the goal is clearly to convert all medical devices to MDR as soon as possible. 

At the same time as the MDR certification, we also had our quality management system for medical devices according EN ISO 13485 successfully recertified by TÜV Süd. 
In addition, the entire company is also certified according to ISO 9001:2015 quality management.

Our guidelines concerning occupational safety and health protection are based on OHSAS 18001:2007 This is particularly reflected in

• compliance with the applicable legal obligations
• a safe infrastructure through regular maintenance and renewal of buildings and facilities
• an active prevention of accidents through risk analysis and
• a rapid intervention in the event of accidents through a clearly structured emergency organisation