Page 18 - Shimadzu Journal vol.2 Issue2

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manufactured at Shimadzu USA Manufacturing (SUM) located in
manufacturing of the medical devices mentioned under the FDA
globally recognized international quality management standard
Shimadzu Registers HPLC and LC-MS Instruments as Class I Medical Devices
Canby, Ore. Both facilities obtained ISO 13485 certification, the
The registered instruments were designed in Shimadzu
Corporation’s head office (Sanjo Works, Japan) and
for medical equipment, in 2013. SUM is conducting

regulation 21 CFR 820. Shimadzu Welcomes and Trains Two Vietnam National University Lecturers machines, and analyzed the acquired data. VNU is one of the major centers of advanced education and research in Vietnam. The university and Shimadzu aim to develop and utilize a jointly established cutting-edge research laboratory. As a global company, Shimadzu will continue to actively exchange human resources and conduct business in cooperation with the international community.

global w430×h280 with US Food and Drug Administration In response to a growing need for analytical measurement in healthcare applications, Shimadzu Corporation, Japan, has registered several of the company’s high-performance liquid chromatographs (HPLC) and high-performance liquid chromatograph mass spectrometers (LC-MS) as Class I medical devices with the US Food and Drug Administration (FDA). These are the first Shimadzu analytical instruments registered with the FDA as medical devices. The use of analytical devices in medical screenings and disease prevention has been on the rise in recent years. Starting in July 2011, the FDA required manufacturers to register analytical instruments as Class I medical dev