Quality Management System

The engineering and manufacturing services are rigorously supported by the Quality management systems in place that ensure full regulatory compliance. Risk management according to ISO 14971:2003 are integrated in the quality system.

We are registered as an FDA Device Manufacturing establishment and our quality management system complies with FDA 21 CFR 820 (FDA Audit Spring 2008). In addition, we are certified according to ISO 13485:2003 and ISO 14001:2004.