LC/MS Manufacturing Achieves ISO 13485 Certification

Agilent Technologies, Inc announced that its liquid chromatography/mass spectrometry systems, including 6100 Series single quadrupole and 6400 Series triple quadrupole systems, are now manufactured under ISO 13485 certification. This is an internationally recognised standard of quality management for the design and manufacture of medical devices. “This is just the latest step that Agilent has taken to clear the way for use of our life science tools in the clinic,” said Gustavo Salem, Agilent Vice President and General Manager, Biological Systems Division. “We’re also in talks with the FDA about requirements for clearing a number of our platforms, and we’re being very methodical and deliberate about this.”

“These systems are well-proven in toxicology, clinical research, metabolomics, proteomics and chemical analysis,” added John Fjeldsted, Agilent General Manager, LC/MS. “There’s value in having the additional validation of an ISO 13485-registered quality management system on top of our own high standards of quality design and manufacturing as we pursue approval for the clinic.”