Shimadzu said this week that its US manufacturing subsidiary Shimadzu USA Manufacturing has obtained ISO 13485 certification for the manufacture of its liquid chromatography and mass spectrometry systems.
The certification allows SUM to manufacture these instruments for clinical testing in the US market.
"Mass spectrometry has a growing presence in clinical research and laboratory medicine," Shinichi Matsunaga, president of Shimadzu U.S.A. 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."
The company added that it will continue to registed medical devices with the US Food and Drug Administration, "and support the growing demand for LC and LC-MS in the clinical testing market."
To date, Shimadzu has not registered any of its LC-MS systems with FDA as class I exempt medical devices, a requirement for their use in clinical applications.