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AB Sciex Gains ISO 13485 Certification, Eyeing Clinical Adoption of LC-MS

NEW YORK (GenomeWeb News) – AB Sciex today said that it has achieved ISO 13485 certification for its quality management system, as the firm considers gaining regulatory clearance of its liquid chromatography-mass spectrometry systems for clinical use.

ISO 13485 is an international standard requiring a manufacturer to show a comprehensive and compliant quality management system that is suitable for the design and manufacture of medical devices, AB Sciex, a Danaher company said, adding that ISO certification is considered a first step toward achieving European regulatory requirements for a device to be used in the clinic.

AB Sciex instruments are currently for research-use only.

The ISO 13485 certification covers AB Sciex's manufacturing facility in Singapore and its R&D design center in Toronto.

"AB Sciex is taking the necessary steps to be compliant with regulatory requirements that govern entry into clinical diagnostics," Rainer Blair, president of AB Sciex, said in a statement. "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."