NanoString Technologies, Inc., a privately held life sciences company marketing a complete solution for detecting and counting large sets of target molecules in biological samples, today announced it has received ISO 13485:2003 certification, an internationally recognized quality standard for medical devices.
The ISO 13485:2003 certification covers the design, development, production, sales and service of the nCounter® Analysis System, NanoString’s multiplexed molecular detection instrument and reagents. The certificate demonstrates that NanoString has successfully implemented a quality management system that conforms to the worldwide standard for medical device and diagnostic manufacturing.
nCounter Analysis System
“This achievement demonstrates NanoString’s continued commitment to the highest level of quality management and design controls to ensure delivery of safe and effective products,” said Mary Tedd Allen, Vice President of Manufacturing for NanoString. “Our international customer base can be assured that the products we deliver today are of the highest standards, and that the ISO 13485:2003 criteria will provide a quality foundation upon which we and our partners will develop new diagnostic products.”
The ISO (International Organization for Standardization) is the world's largest developer and publisher of International Standards. NanoString’s ISO 13485:2003 certificate was awarded by LNE / GMED through its subsidiary GMED North America, Inc.