AB SCIEX Achieves ISO 13485 Certification for Manufacturing of LC/MS Systems
Published: Feb 27, 2012
FRAMINGHAM, Mass.--(BUSINESS WIRE)--AB SCIEX, a global leader in life science analytical technologies, today 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 manufacturers and sells LC/MS/MS systems for research use only.