Quality and environmental management systems
Forstec Dental AB has a quality management system that meets the requirements of ISO 9001 and a quality management system for medical devices that meets the requirements of ISO 13485. We are also environmentally certified according to ISO 14001.
Regarding the medical devices that Forstec markets as a wholesaler, Forstec verifies the product’s CE marking and the EU Declaration of Conformity on which the CE marking is based.
Medical devices manufactured by Forstec itself (custom-made products) meet safety and performance requirements in accordance with (EU) 2017/745 MDR, Annex I.
Our production center OpenMill, which manufactures CAD/CAM-produced prosthetic restorations for dental technical use, is also approved by the Swedish Medical Products Agency as a dental laboratory. The accredited certification body that is our partner is RISE, formerly the Swedish Institute for Technical Research.
Swedish Medical Products Agency registration certificate PDF
Forstec Sustainability Policy
Forstec Dental applies a sustainability and life-cycle perspective in its processes and decisions. For more information about what this means, please continue reading in the Forstec sustainability policy PDF. Sustainability Policy PDF
Safety data sheets
If you need safety data sheets, please call the relevant customer service department using the telephone numbers below or email info@forstec.se.
