Certificates
Highest qualitity standards are our commitment. To achieve this goal, we challange ourselves and our processes regularly and get them tested and certified by independent authorities. Below you will find some certificates. For other specific certificates do not hesitate to contact us accordingly.
EN ISO 13485
GFE has implemented a medical device quality managment system according to EN ISO 13485.
EC Certificate
GFE´s quality system meets all requirements according to Annex IV – excluding Section 4 and 6 of the Council Directive 98/79/EC.
EU QMS Certificate (IVDR)
GFE´s quality system meets all requirements according to Annex IX Chapters I and III (Class D Devices) of the Regulation (EU) 2017/746 on in Vitro Diagnostic Medical Devices.
Brochures
Find supporting marketing material.
GFE PoET Brochure 2022
Get an overview of our PoET® Instrument
Doc. HO 000642