SCIEX Achieves ISO 13485 Certification for Manufacturing of LC/MS Systems
“SCIEX is taking the necessary steps to be compliant with regulatory requirements that govern entry into clinical diagnostics,” said Rainer Blair, President of SCIEX.
February 27, 2012
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. SCIEX currently manufactures and sells LC/MS/MS systems for research use only.
"SCIEX is taking the necessary steps to be compliant with regulatory requirements that govern entry into clinical diagnostics," said Rainer Blair, President of 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 SCIEX's manufacturing facility in Singapore as well as its R&D design center in Toronto, Canada. 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 SCIEX instruments as well as the company's commitment to continuous improvement.
SCIEX helps to improve the world we live in by enabling scientists and laboratory analysts to push the limits in their field and address the complex analytical challenges they face. The company's global leadership and world-class service and support in the mass spectrometry industry have made it a trusted partner to thousands of the scientists and lab analysts worldwide who are focused on basic research, drug discovery and development, food and environmental testing, forensics and clinical research. With over 20 years of proven innovation, SCIEX excels by listening to and understanding the ever-evolving needs of its customers to develop reliable, sensitive and intuitive solutions that continue to redefine what is achievable in routine and complex analysis. Follow SCIEX on Twitter @ABSCIEX and on Facebook and LinkedIn.
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