US-based Thermo Fisher Scientific has announced that its US-based facilities have received ISO 13485 certification.
The facilities in Franklin, Massachusetts and San Jose, California are the company's liquid chromatography and mass spectrometry sites.
Under the standard, Thermo Scientific TLX multiplexed high performance liquid chromatography (HPLC) platforms and various mass spectrometry systems will be designed and manufactured.
The company said designing and manufacturing will pave the way for CE-IVD device registration in Europe and Class-1 medical device listing in the US.
Thermo Fisher chromatography and mass spectrometry business president Dan Shine said this is a critical step in the company's ongoing initiative to develop liquid chromatography-mass spectrometry (LC-MS) devices for the clinical market.
"The medical community is expressing great interest in utilizing LC-MS technology, and we're aggressively developing tools to address this growing demand," Shine added.
