Beverly, MA (February 15, 2012) – BioHelix Corporation today announced that the company has earned the International Organization for Standardization (ISO) 13485:2003 certification for its Beverly, Massachusetts headquarters manufacturing facility. ISO 13485 is an internationally recognized standard that specifies requirements for quality management systems of medical device manufacturers. Achieving ISO 13485 Certification is a significant quality milestone, said Huimin Kong, president and CEO of BioHelix. "This important certification helps confirm our commitment to provide customers with the highest quality products and services. We are very proud of this achievement". The company plans to launch several IVD products in Europe in 2012 .
The quality management systems certification audit was performed by National Standards Authority of Ireland (NSAI), Eastern Region, Nashua, USA.