ISO 13485 certification for Agilent Technologies

Agilent Technologies has announced that its LC?MS systems, including the 6100 Series single quadrupole and 6400 Series triple quadrupole systems are now manufactured under ISO 13485 certification.

Agilent Technologies has announced that its LC–MS systems, including the 6100 Series single quadrupole and 6400 Series triple quadrupole systems are now manufactured under ISO 13485 certification. This is an internationally recognized 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.”

John Fjeldsted, Agilent general manager, LC–MS, noted that this additional validation on top of their own high standards of quality design and manufacturing would add value to their systems and their use in the clinic.

For more information, visit www.agilent.com