Quality and Sustainability
Stille’s products are famous for their high and consistent quality, with a 30-year warranty on all surgical instruments. Quality management and quality assurance is a part of almost every daily task at Stille.
Stille uses a quality management system that is certified to the ISO 13485:2016 standard for medical devices. Our ISO 13485 certification covers everything from design to manufacturing, sales and service.
Our quality management focuses on assuring full patient security and the fulfilment of all national, regional laws, regulations and standards that are applicable for our products and operations.
All employees follow the routines and directives stipulated by our quality management system. Quality focus is also an important part of our code of conduct.
We also comply with the EU directive medical Devices Directive (MDD). MDD will be replaced by a new directive: the Medical Device Regulation (MDR). We are in the process of updating our quality management system for full compliance with MDR. This is done together with our notified body Intertek.