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

22-05-2012: AB SCIEX announced 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.  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 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.