“SCIEX is taking the necessary steps to be compliant with regulatory requirements that govern entry into clinical diagnostics,” said Rainer Blair, President of SCIEX.
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 mass spectrometry portfolio