Vigmed granted Quality System Certification
Vigmed, having completed the establishment of a Quality Management System, and has now been granted Quality System Certificate for both EN ISO 13485:2012 and EN ISO ISO9001:2008 (issued by Presafe A/S). The scope of the Certification includes development & manufacturing of solutions to prevent needle stick injuries. The 13485:2012 standard includes Quality Management System requirements for medical devices specifically for regulatory purposes. It is based on the ISO9001 standard and is also harmonized with FDA regulations. It provides a framework for a manufacturer to meet the Quality