To meet health, safety, environmental and sustainability requirements, the quality of our products is paramount. Before we market our products, they are subjected to stringent quality controls. All our products meet the essential requirements for medical devices according to European legislation and bear the required CE mark.
Our company holds ISO 13485* certification and also ISO 13485 MDSAP certification for the countries of Australia, Brazil, Canada and the United States under the international Medical Device Single Audit Program (MDSAP).
The medical devices developed and manufactured by our company itself have all been CE-marked in accordance with EU legislation and we hold the required CE certificates for these products. These products are exported worldwide.
* ISO 13485 is the quality standard for companies that manufacture and/or market medical devices.