Agilent Technologies' LC/MS Manufacturing Achieves ISO 13485 Certification

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.

In March 2010, Agilent achieved ISO 13485 certification for the design and manufacture of its entire portfolio of DNA microarrays and microarray scanner platform. In June 2011, Agilent announced that its Cedar Creek, Texas, reagent manufacturing facility has been registered with the U.S. Food and Drug Administration as a medical device establishment. This registration is required for the manufacture of diagnostic products.