Pre-qualified to DS/EN ISO 13485:2012
In May 2013 our quality system QMS was prequalified by DGM/Presafe according to DS/EN ISO 13485:2012
For the past 2 years, Technolution has been upgrading the internal quality system QMS to meet the high demands on quality from customers and authorities, regarding products and documentation. Today, we are able to implement all in-house development in accordance to the Medical Devices directive and the In Vitro Diagnostic directive.
Our QMS focuses specifically on the development process and addresses activities and documentation from idea to final CE approvement – including complete design control. Furthermore, we focus on Risk Management (EN ISO 14971:2012) and Usability Engineering (IEC 62366:2007)
Technolution expects to receive its final certification in the beginning of 2014.