The Department of Energy's Oak Ridge National Laboratory and SCIEX of Framingham, Mass., have signed a licensing agreement for technologies that speed up, simplify and expand the use of analytic chemistry equipment. SCIEX is a manufacturer of mass spectrometers used to identify and characte ... more
AB SCIEX Achieves ISO 13485 Certification for Manufacturing of LC/MS Systems
AB SCIEX announced that it has achieved ISO 13485 certification for its quality management system. ISO 13485 is an international standard that requires a manufacturer to demonstrate a comprehensive and compliant quality management system suitable for the design and manufacturing of medical devices. This ISO certification is often considered a first step toward complying with European regulatory requirements for a device to be cleared for use in the clinic. AB SCIEX currently manufactures and sells LC/MS/MS systems for research use only.
“AB SCIEX is taking the necessary steps to be compliant with regulatory requirements that govern entry into clinical diagnostics,” said Rainer Blair, President of AB SCIEX. “Achieving the ISO 13485 certification is an important measure toward realizing the vision of our LC/MS/MS systems to be cleared for use in clinics. The potential impact of mass spectrometry technologies on clinical diagnostics is significant.”
The ISO 13485 certification covers AB SCIEX’s manufacturing facility in Singapore as well as its R&D design center in Toronto, Canada.
- AB SCIEX
- DIN EN ISO 13485
- quality management systems
- medical devices
The Human Proteome Organization (HUPO) will award Christie Hunter, Ph.D, director of proteomics applications at AB SCIEX, its 2013 Science and Technology Award at an award ceremony HUPO 2013 conference in Japan. Dr. Hunter is being recognized for her contributions to the development and co ... more
AB SCIEX announced a collaboration with Landeswasserversorgung Water Supply, one of the foremost water supply and treatment organizations in Europe, to improve the identification of contaminants in drinking water. Scientists at the waterworks in Langenau are using a new generation of mass s ... more
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