May 11 2010
A privately held life sciences vendor NanoStrings that markets a total solution for identifying and counting large target molecules sets in biological samples, has been awarded the ISO 13485:2003 certification that is a medical devices quality standard recognized internationally.
This certificate covers issues relating to the nCounter Analysis System Nanostring’s design, creation, manufacture, sales and service of multiplexed type of molecular detection reagents and instruments. The certificate proves that NanoString has implemented its quality management system successfully, which adheres to the global standards for medical device and diagnostic production.
NanoString nCounter Analysis System
The International Organization Standard (ISO) is the largest publisher and developer of International Standards in the world. The LNE/GMED awarded the ISO 13485:2003 certificate to NanoStrings through GMED North America, its subsidiary.
NanoString’s Vice President for manufacturing Mary Tedd Allen informed that this award highlights her company’s continued focus for the highest design controls and quality management levels for ensuring effective and safe products. She added that her company’s global customers can be assured that the products delivered to them are the ones with the highest standards. She explained that the ISO certification will create a quality foundation on which the company and its partners will create more diagnostic products.