Two Thermo Fisher Scientific Facilities Achieve ISO 13485 Certification
04 Apr 2013

Thermo Fisher Scientific Inc., the world leader in serving science, today announced that its facility in San Jose, Calif. and its Franklin, Mass site have achieved ISO 13485 certification, an internationally recognized standard of quality management for the design and manufacture of medical devices.
The sites in Franklin and San Jose are the first of Thermo Fisher’s liquid chromatography and mass spectrometry sites to achieve ISO 13485 certification.


Thermo Scientific TLX multiplexed HPLC (high performance liquid chromatography) platforms and a number of Thermo Scientific mass spectrometry systems will be designed and manufactured under this standard, paving the way for CE-IVD device registration in Europe and Class-1 medical device listing in the United States, the company said.

“This is a critical step in our ongoing initiative to develop LC-MS (liquid chromatography-mass spectrometry)-based devices for the clinical market,” said Dan Shine, president of Thermo Fisher’s chromatography and mass spectrometry business. “The medical community is expressing great interest in utilizing LC-MS technology, and we’re aggressively developing tools to address this growing demand.”

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Sarah Thomas
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