NEW YORK (GenomeWeb News) – Shimadzu USA Manufacturing said today it has obtained ISO 13485 certification for the manufacture of high performance liquid chromatographs and liquid chromatograph-mass spectrometry systems.
The certification allows Shimadzu USA Manufacturing to manufacture and supply analytical instruments for clinical testing in the US market, the company said, adding it will continue to register devices with the US Food and Drug Administration and support the growing demand for LC and LC-MS in the clinical testing space.
"Mass spectrometry has a growing presence in clinical research and laboratory medicine," Shinichi Matsunaga, president of Shimadzu USA Manufacturing, said in a statement. "Achieving ISO 13485 certification is a major milestone for Shimadzu and a great step towards developing mass spectrometry platforms as next-generation medical devices."
Shimadzu USA Manufacturing is the US manufacturing subsidiary of Shimadzu Corp., and is based in Canby, Ore.