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Shimadzu Achieves ISO 13485 Certification for US LC-MS Facility

Published: Wednesday, September 25, 2013
Last Updated: Wednesday, October 16, 2013
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ISO 13485 is the globally recognized international quality management standard for medical equipment.

Shimadzu U.S.A Manufacturing, Inc. the U.S. manufacturing subsidiary of Shimadzu Corporation, has obtained ISO 13485 certification for the manufacture of high-performance liquid chromatographs (LC) and high-performance liquid chromatograph mass spectrometers (LCMS). 

As a result of the increased use of analytical instruments in the clinical field, the U.S. FDA (Food and Drug Administration) announced draft guidance in June 2011, requiring a clearer distinction between research equipment and IVD (in vitro diagnostic devices). This demands a strict management system to ensure the reliability and accuracy of analytical instruments when used as medical equipment. Manufacturers must first comply with the ISO 13485 standard, and thereafter follow the laws and regulations in each country and region. In other words, obtaining ISO 13485 certification is now a prerequisite when using analytical instruments as medical equipment.

In April 2013, Shimadzu Corporation expanded the scope of its ISO 13485 certification, which covered blood coagulation and automatic clinical chemistry analyzers, to include LCMS and LC instruments. Obtaining ISO 13485 certification allows SUM to manufacture and supply analytical instruments for clinical testing to the U.S. market. Shimadzu will continue to register medical devices with the FDA, and support the growing demand for LC and LCMS in the clinical testing market.

"Mass spectrometry has a growing presence in clinical research and laboratory medicine," said Shinichi Matsunaga, President of Shimadzu U.S.A. Manufacturing. "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 U.S.A. Manufacturing (SUM) will continue to promote activities to obtain ISO 13485 certification for other analytical instruments planned to advance into the clinical testing market. In addition, SUM will build an efficient manufacturing system as a production base to supply medical equipment devices to customers throughout the world.

Simultaneous multicomponent analysis using Shimadzu's high-speed, high-sensitivity mass spectrometers is expected to demonstrate considerable value in the clinical field. Marking this occasion of ISO 13485 certification, Shimadzu will accelerate expansion of analytical and measuring instruments into the medical field and continue to fulfill our management principle of "Realizing Our Wishes for the Well-being of both Mankind and the Earth"


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