Our production facility follows current Good Manufacturing Practice (cGMP) as required by the US’s Food & Drug Administration (FDA).

 

This enables us to provide systems that assure proper design, monitoring, and control of Processes within the manufacturing facility. This also enable us to have our Products CE approved to EN 14683 standard.  

 

Using our strict quality procedures working to ISO 13485:2016 and clean room ISO 14644-1:2015  we maintain high standards of quality and control.