Corporate Banner
Satellite Banner
Scientific Community
Become a Member | Sign in
Home>News>This Article

AB SCIEX Achieves ISO 13485 Certification for Manufacturing of LC/MS Systems

Published: Monday, February 27, 2012
Last Updated: Monday, February 27, 2012
Bookmark and Share
This ISO certification is often considered a first step toward complying with European regulatory requirements for a device to be cleared for use in the clinic.

AB SCIEX announce that it has achieved ISO 13485 certification for its quality management system.  ISO 13485 is an international standard that requires a manufacturer to demonstrate a comprehensive and compliant quality management system suitable for the design and manufacturing of medical devices.  AB SCIEX currently manufactures and sells LC/MS/MS systems for research use only.  

“AB SCIEX is taking the necessary steps to be compliant with regulatory requirements that govern entry into clinical diagnostics,” said Rainer Blair, President of AB SCIEX.  “Achieving the ISO 13485 certification is an important measure toward realizing the vision of our LC/MS/MS systems to be cleared for use in clinics.  The potential impact of mass spectrometry technologies on clinical diagnostics is significant.”

The ISO 13485 certification covers AB SCIEX’s manufacturing facility in Singapore as well as its R&D design center in Toronto, Canada.  AB SCIEX is a leader with more than 20 years of innovation and market leadership. Its instrumentation is used in clinical research, forensic toxicology, biomedical research and drug discovery and development.  The achievement of ISO certification offers customers and suppliers an additional level of confidence in the quality and reliability of AB SCIEX instruments as well as the company’s commitment to continuous improvement.

Further Information
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 2,800+ scientific posters on ePosters
  • More than 4,000+ 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 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

SCIEX, University of Manchester Partner
SWATH® Acquisition-based next-generation proteomics technology promises to make industrial proteomics a reality.
Thursday, October 29, 2015
SCIEX and New Objective Announce Partnership
New nanospray sources to offer maximum sensitivity and robustness for NanoLC-MS.
Tuesday, June 02, 2015
SCIEX and New Objective Partner
Partnership will provide advanced nanospray ionization technologies for next-generation proteomics.
Tuesday, May 26, 2015
Dr. Gyula Vigh wins Arnold O. Beckman Award
SCIEX sponsored award recognizes outstanding contributions to the field of electrodriven separation techniques.
Thursday, May 07, 2015
New Capabilities for Bioanalysis Studies at the International Pharmaceutical Research Center
AB SCIEX Triple Quad™ 6500 LC/MS/MS systems enable new levels of sensitivity for clinical trials of inhaled drugs.
Wednesday, February 11, 2015
AB SCIEX Scientist Wins HUPO 2014 Science and Technology Award
Winner becomes second team member to be recognized for the commercialization of transformative chemistries such as iTRAQ® eagents.
Monday, October 06, 2014
AB SCIEX, Dalton Pharma Services Announce ADC Partnership
Research collaboration aims to develop Antibody-Drug Conjugate analysis capabilities.
Wednesday, August 27, 2014
Barry Karger Receives Arnold O. Beckman Award
Award honors Prof Karger for his outstanding achievements in the field of electrodriven separation techniques.
Monday, April 28, 2014
AB SCIEX to Present ESI-MS Workshop
The workshop will be presented at HPLC 2014.
Tuesday, April 22, 2014
Halal Meat Authenticity Testing Reassures Consumers of No Pig or Horse Contamination
New LC/MS/MS-based meat speciation method allows food testing laboratories to detect pig and horse contamination in diverse food products, with higher accuracy than existing methods.
Tuesday, January 28, 2014
AB SCIEX Brings MASStastic Voyage to Ireland
The tour features a state-of-the-art mobile laboratory and will coincide with a special conference being held by the Irish Separation Science Cluster (ISSC).
Monday, November 11, 2013
AB SCIEX Expands in Singapore
AB SCIEX announce the next major phase of its expansion in Singapore, with the grand opening of a new R&D centre.
Friday, November 01, 2013
AB SCIEX Proteomics Scientist Wins HUPO 2013 Science and Technology Award
Dr. Christie Hunter is being recognized for her contributions to the development and commercialization of a breakthrough approach for targeted proteomics.
Tuesday, September 10, 2013
AB Sciex to Combine Eksigent Chromatography with Capillary Electrophoresis from Beckman
The move brings together Beckman Coulter’s expertise in microscale separation with the expertise in microfluidics of the Eksigent chromatography team of AB Sciex.
Thursday, July 11, 2013
AB SCIEX and LECO Announces Co-marketing Agreement
Bundled solutions leverage the synergy between two technology leaders.
Thursday, July 04, 2013
Scientific News
High Throughput Mass Spectrometry-Based Screening Assay Trends
Dr John Comley provides an insight into HT MS-based screening with a focus on future user requirements and preferences.
New Analysis Technique for Chiral Activity in Molecules
Professor Hyunwoo Kim of the Chemistry Department and his research team have developed a technique that can easily analyze the optical activity of charged compounds by using nuclear magnetic resonance (NMR) spectroscopy.
Metabolic Profiles Distinguish Early Stage Ovarian Cancer with Unprecedented Accuracy
Studying blood serum compounds of different molecular weights has led scientists to a set of biomarkers that may enable development of a highly accurate screening test for early-stage ovarian cancer.
Genetically Engineering Algae to Kill Cancer Cells
New interdisciplinary research has revealed the frontline role tiny algae could play in the battle against cancer, through the innovative use of nanotechnology.
Acetaldehyde and Formaldehyde Content in Foods
Korean researchers have determined the content of the toxic and carcinogenic aldehydes, acetaldehyde and formaldehyde, in a variety of food groups.
Combining the Power of Mass Spectrometry & Microscopy
A tool that provides world-class microscopy and spatially resolved chemical analysis shows considerable promise for advancing a number of areas of study, including chemical science, pharmaceutical development and disease progression.
Advancing Lithium-Ion Battery Research
The increasing number of components in a lithium-ion battery makes it essential to use a variety of analytical methods to attain complete characterization.
Fruit Fly Pheromone Flags Great Real Estate for Starting a Family
Finding could aid efforts to control mosquito-borne diseases like malaria by manipulating odorants
Education and Expense: The Barriers to Mass Spectrometry in Clinical Laboratories?
Here we examine the perceived barriers to mass spec in clinical laboratories and explore the possible drivers behind the recent shift in uptake of the technology in clinical settings.
Metabolomic Platform Reveals Fundamental Flaw in Common Lab Technology
A new study led by scientists at The Scripps Research Institute (TSRI) shows that a technology used in thousands of laboratories, called gas chromatography mass spectrometry (GC-MS), fundamentally alters the samples it analyzes.

Skyscraper Banner
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
2,800+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,000+ scientific videos