EntroGen, Inc has received ISO 13485:2003 certification from NSF for the quality management system of its medical devices. The certification covers design, development, manufacturing and sale of research and diagnostic tools.
ISO 13485 is an international standard that specifies requirements for medical device manufacturers. The main goal of ISO 13485 is to provide a harmonized model for quality management system requirements in the international market. ISO 13485 compliance is therefore of critical importance.