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AB Sciex has announced that it has achieved ISO 13485 certification for its quality management system.
AB Sciex has announced that it has achieved ISO 13485 certification for its quality management system. This certification requires a manufacturer to demonstrate a compliant quality management system suitable for the design and manufacturing of medical devices. It covers the manufacturing facility in Singapore and the R&D design centre in Toronto. With this, AB Sciex is coming closer to complying with European regulatory standards for a device to be cleared for use in the clinic.
Rainer Blair, President of AB Sciex, commented, “AB Sciex is taking the necessary steps to be compliant with regulatory requirements that govern entry into clinical diagnostics. 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.”