Corporate Banner
Satellite Banner
Mass Spectrometry
Scientific Community
 
Become a Member | Sign in
Home>News>This Article
  News
Return

Shimadzu Achieves ISO 13485 Certification for US LC-MS Facility

Published: Wednesday, September 25, 2013
Last Updated: Wednesday, October 16, 2013
Bookmark and Share
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increased use of analytical instruments in the clinical field, the U.S. FDA (Food and Drug Administration) announced draft guidance in June 2011, requiring a clearer distinction between research equipment and IVD (in vitro diagnostic devices).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"


Further Information

Join For Free

Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 4,000+ scientific posters on ePosters
  • More than 5,300+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

Shimadzu, Indigo BioSystems Announce Partnership
The companies will leverage the power of ASCENT™ clinical solutions on ultra-fast mass spectrometry platforms.
Monday, June 16, 2014
Shimadzu Corporation, MacCoss Lab of Biological Mass Spectrometry, UW Collaborate
The companies will leverage the power of ASCENT™ clinical solutions on ultra-fast mass spectrometry platforms.
Monday, June 16, 2014
Shimadzu Registers HPLC and LCMS Instruments as Class I Medical Devices with FDA
Products are the first Shimadzu analytical instruments registered with the FDA as medical devices.
Tuesday, April 01, 2014
Shimadzu Establishes Latin American Subsidiary
Uruguayan subsidiary will strengthen company's sales and distribution whilst providing better support for customers and distributors in Central and South America.
Tuesday, November 12, 2013
Shimadzu UK Grows Sales Orders by 30%!
Company has achieved sales order growth across many products in the Shimadzu range.
Tuesday, May 07, 2013
Shimadzu and The University of Texas Form Shimadzu Center for Advanced Analytical Chemistry
Located in the university’s Chemistry & Physics Building, the center contains $6 million of chromatography, mass spectrometry and spectroscopy equipment, which is the largest installation of Shimadzu analytical instrumentation in the Western Hemisphere.
Tuesday, April 10, 2012
Shimadzu UK Opens Evaluation Laboratory Centre to Promote Excellence in Analytical Instrumentation
New 1500m² world-class product evaluation laboratory facility at UK headquarters in Buckinghamshire.
Wednesday, July 13, 2011
Shimadzu, Ceres Nanosciences and Nonlinear Dynamics Introduce Nanotrap™ Biomarker Discovery Platform
Shimadzu Scientific Instruments has partnered with Ceres Nanosciences and Nonlinear Dynamics to bring the future of biomarker discovery to laboratory researchers.
Tuesday, March 16, 2010
Shimadzu and Phenomenome Discoveries Announce Exclusive Collaboration
Shimadzu and PDI will develop software tools for global profiling using high mass accuracy MSn data.
Monday, July 02, 2007
Shimadzu Assumes Responsibilities for X-ray Spectrometer Business
Shimadzu transfers the X-ray spectrometer business from Kratos Analytical to SSI, which will handle sales and service of X-ray spectrometers in US, Canada, and Mexico.
Wednesday, March 07, 2007
Shimadzu HPLCs Used for Finding Cancer Treatment
Researchers are using LC10 Vp series and Prominence high performance liquid chromatography systems.
Thursday, November 09, 2006
Scientific News
Metabolite Promotes Cancer Cell Transformation
Researchers have identified a metabolite that promotes cancer cell transformation and colorectal cancer spread.
Top 10 Life Science Innovations of 2016
2016 has seen the release of some truly innovative products. To help you digest these developments, The Scientist have listed their top picks for the year.
Hunting the Missing Link Between Genetics and the Environment
The International Phenome Centre Network (IPCN) works to transform healthcare through phenomics - the dynamic interactions between our genes and our environment.
Cocaine Test Could Lead to Rapid Roadside Testing
Scientists develop urine and oral fluid diagnostic test for cocaine, utilising a compact mass spectrometer.
The Benefits of a Mediterranean-style Diet
A Western-style diet, with more omega-6 fatty acids than the Mediterranean, dysregulates lipid signaling in aged mice and promotes inflammation.
Peer Review is in Crisis, But Should be Fixed, Not Abolished
After the time to get the science done, peer review has become the slowest step in the process of sharing studies, and some scientists have had enough.
Rapid Identification of Illicit Designer Drugs
New technique can identify commonly used illicit compounds in as little as 15 seconds.
Enhancing On-line Biological Sample Processing
New techniques are required to meet emerging demands on biopharmaceutical analysis.
Early Warning System for Colorectal Cancer
Potential new diagnostic tool identified for the second most common cancer in the world.
Scientists Develop a Novel Method to Benchmark and Improve the Performance of Protein Measurement Techniques
A wide range of laboratories around the world are benefiting from this work, which enables researchers to analyze or compare the results of quantitative proteomics assays in a standardized way.
Scroll Up
Scroll Down
SELECTBIO

SELECTBIO Market Reports
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
4,000+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
5,300+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!