Quality and environmental management system

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.

For the medical devices that Forstec markets as a wholesaler, Forstec checks the CE marking of the product and the EU Declaration of Conformity on which the CE marking is based.

Medical devices manufactured by Forstec itself (customized products) meet the safety and performance requirements of (EU) 2017/745 MDR, Annex I.

Vårt produktionscenter OpenMill som tillverkar CAD/CAM-framställda protetiska ersättningar för tandtekniskt bruk är också godkänt av Läkemedelsverket som tandtekniskt laboratorium. Det ackrediterade organ för certifiering som är vår partner är RISE, tidigare Sveriges Tekniska Forskningsinstitut.
ISO 14001 PDF
ISO 13485 PDF
ISO 9001 PDF
Registreringsbevis Läkemedelsverket PDF

Forstec Sustainability Policy

Forstec Dental has a sustainability and life cycle perspective in processes and decisions. For more info on what this means, read on at Forstec sustainability policy pdf.
Sustainability policy PDF

Safety data sheets

If you need a safety data sheet, please call the respective customer service on the telephone number below or email info@forstec.se.

We are environmentally certified
according to ISO 14001

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