Corporate Banner
Satellite Banner
Molecular & Clinical Diagnostics
Scientific Community
 
Become a Member | Sign in
Home>News>This Article
  News
Return

Thermo Fisher Scientific Facilities Achieve ISO 13485 Certification

Published: Thursday, April 04, 2013
Last Updated: Thursday, April 04, 2013
Bookmark and Share
The facilities in San Jose, CA and Franklin, MA have achieved the 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-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.” 



Further Information

Join For Free

Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 3,100+ scientific posters on ePosters
  • More than 4,500+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

Thermo Fisher Scientific to Acquire Life Technologies Corporation
The definitive agreement will see Thermo Fisher will acquire Life Technologies for $76.00 in cash per fully diluted common share or approximately $13.6 billion.
Monday, April 15, 2013
Thermo Fisher Scientific Reports Q3 Revenue and EPS Results
Revenue increased 5% to a record $3.09 billion for the third quarter with adjusted operating income rising 5% to $576 million.
Wednesday, October 24, 2012
Thermo Scientific Elects New Director to Board
Appointment of C. Martin Harris to Company’s board of directors.
Monday, March 26, 2012
Thermo Fisher Scientific Introduces Unity Lab Services
The new offering combines product and laboratory support services to create a single solution for customers to optimize productivity and reduce their total cost of laboratory operations.
Monday, January 09, 2012
Thermo Fisher Scientific Opens New Biomarker Translational Center
Goal is to accelerate MS-based biomarker discovery and its translation into development of routine clinical assays.
Wednesday, September 07, 2011
Scientific News
Grant Supports Project To Develop Simple Test To Screen For Cervical Cancer
UCLA Engineering announces funding from Bill and Melinda Gates Foundation.
Loss Of Y Chromosome Increases Risk Of Alzheimer’s
Men with blood cells that do not carry the Y chromosome are at greater risk of being diagnosed with Alzheimer’s disease. This is in addition to an increased risk of death from other causes, including many cancers. These new findings by researchers at Uppsala University could lead to a simple test to identify those at risk of developing Alzheimer’s disease.
Making Virus Sensors Cheap and Simple
Researchers at The University of Texas at Austin demonstrated the ability to detect single viruses in a solution containing murine cytomegalovirus (MCMV).
Heart Defect Prediction Technology Could Lead to Earlier, More Informed Treatment
Experimental method uses genetics-guided biomechanics, patient-specific stem cells.
Biosensor Detects Molecules Linked to Cancer, Alzheimer's and Parkinson's
Novel biosensor has been proven capable of detecting molecules associated with neurodegenerative diseases and some types of cancer.
Big Data Can Save Lives
The sharing of genetic information from millions of cancer patients around the world could be key to revolutionising cancer prevention and care, according to a leading cancer expert from Queen's University Belfast.
Fast, Simple Test for Colitis
A minimally invasive screening for ulcerative colitis using emerging infrared technology could be a rapid and cost-effective method for detecting disease that eliminates the need for biopsies and intrusive testing of the human body.
Scans Reveal Babies of Mothers with Gestational Diabetes Have More Body Fat
Researchers at Imperial College London have found that the babies born to mothers with gestational diabetes have more body fat at two months of age compared to babies born to healthy mothers.
New Device Could Improve Cancer Detection
UBC researchers develop a microfluidic device to capture circulating tumor cells.
Plasma Biomarkers for Breast Cancer Diagnosis
Plasma lipidomics profiling identified lipid biomarkers in distinguishing early-stage breast cancer from benign lesions.
Skyscraper Banner

SELECTBIO Market Reports
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
3,100+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,500+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!