Two Thermo Fisher Scientific Facilities Achieve ISO 13485 Certification
Distinction certifies facilities' quality management system for medical devices.
- (1888PressRelease) April 04, 2013 - SAN JOSE, Calif.- 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."
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science. Our mission is to enable our customers to make the world healthier, cleaner and safer. With revenues of $13 billion, we have approximately 39,000 employees and serve customers within pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research institutions and government agencies, as well as in environmental and process control industries. We create value for our key stakeholders through three premier brands, Thermo Scientific, Fisher Scientific and Unity™ Lab Services, which offer a unique combination of innovative technologies, convenient purchasing options and a single solution for laboratory operations management. Our products and services help our customers solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity. Visit www.thermofisher.com.
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