High-quality production for every demand
We are experts in high-quality production of catheters for a broad variety of worldwide customers, independent of low or high volumes. No matter if it is just a single prototype, a pilot run of a device or high volume manufacturing – everything is done with the highest degree of professionalism.
State-of-the-art equipment combined with validated processes are the baseline for our high quality devices. Moreover, experienced and skilled operators in our clean rooms take care of our customers’ products and make sure that all the devices show remarkably constant product properties and product quality.
Even prototyping work is done with proper production equipment under regular clean room conditions to make a future transfer into serial manufacturing much easier and faster.
All of this is done to provide an optimal and successful treatment of patients with our customers’ products.
Both facilities in Germany and Romania are certified according to DIN EN ISO 13485:2012, Directive 93/42 EEC.
The German facility also fulfils the GMP requirements and has the necessary infrastructure for the drug coating of balloon catheters.
"Maintaining 100% quality and precision with a maximum of flexibility in a large-scale production – this is a tremendously exciting challenge for me."