AB SCIEX achieves ISO 13485 certification for manufacturing of LC/MS systems, and opens Asia Pacific Application & Training Centre in Singapore’s biomedical hub
AB SCIEX, a global leader in life science analytical technologies, today announced that it has achieved ISO 13485 certification for its quality management system. This certifies 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. Such 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 manufactures and sells LC/MS/MS systems for research use only.
‘AB SCIEX is taking the necessary steps to be compliant with regulatory requirements that govern entry into clinical diagnostics,’ said Rainer Blair, President of AB SCIEX. ‘Achieving the ISO 13485 certification is an important measure toward realising 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 AB SCIEX’s manufacturing facility in Singapore as well as its R&D design center in Toronto, Canada. AB 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 AB SCIEX instruments as well as the company’s commitment to continuous improvement.
AB SCIEX has also announced the opening of its newest APAC Regional Application & Training Centre. Located in Singapore’s biomedical hub at Biopolis, this centre provides comprehensive service, support and application development to enable the scientific community in Singapore and the rest of ASEAN, Australia New Zealand, Japan and Korea to continue its increasing use of mass spectrometry technologies for a broad range of applications. The new Singapore facility complements the regional application support centre that the company opened last year in Shanghai, China.
This Singapore facility serves as a regional hub for the scientific community to learn about the latest innovations in analytical-based laboratory instrumentation. Its primary functions include sample analysis, instrument and workflow demonstrations, comprehensive training programs, region-specific applications development, on-site and remote customer support, and scientific collaborations with research leaders in a variety of life science disciplines. The company has a long history of partnership throughout the life science industry within Singapore and across the Asia Pacific region. It serves a broad range of customers in government agencies, academic research, clinical research and pharmaceutical industries.
‘Leading companies such as AB SCIEX continue to play an important role in the development of Singapore’s biomedical sciences sector by providing the latest tools to advance our efforts in drug discovery research. This new centre is an excellent example of how companies can foster synergies and partnerships with the research community in Biopolis to develop innovative and region-specific solutions for Asia,’ said Mr. Kevin Lai, Deputy Director, Biomedical Sciences, Singapore Economic Development Board.’
‘AB SCIEX continues to be a trusted partner for our customers and collaborators in Singapore and throughout the Asia Pacific region,’ said Johnson Ho, Vice President of Sales, Asia-Pacific. ‘Our new APAC Regional Application & Training Centre represents our commitment to deliver world-class service and support to help our customers address critical issues, such as food safety, environmental contamination and the accuracy of clinical research results.’
AB SCIEX www.absciex.com