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.

Our OpenMill production center, which manufactures CAD/CAM-produced prosthetic replacements for dental 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 Technical Research Institute of Sweden.
ISO 14001 PDF
ISO 13485 PDF
ISO 9001 PDF
Certificate of registration Läkemedelsverket PDF
Sustainability policy ver 5 PDF
Forstec data protection policy GDPR 2018 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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