NEW YORK (GenomeWeb News) – Thermo Fisher Scientific said today that two of its facilities have achieved ISO 13485 certification, moving the company forward in its efforts to develop liquid chromatography-mass spectrometry systems for clinical use.
The facilities in San Jose, Calif., and Franklin, Mass., are the first liquid chromatography and mass spec sites of Thermo Fisher to receive such certification, a standard of quality management for the design and manufacture of medical devices, it said. With the certification, the firm's TLX multiplexed HPLC platforms and a number of its mass specs will be designed and manufactured under this standard, setting the stage for the platforms to potentially receive CE-IVD device registration in Europe and Class-1 medical device listing in the US, Thermo Fisher said.
"This is a critical step in our ongoing initiative to develop LC-MS-based devices for the clinical market," Dan Shine, president of Thermo Fisher's chromatography and mass spec business, said in a statement. "The medical community is expressing great interest in utilizing LC-MS technology, and we're aggressively developing tools to address this growing demand."