Oxford, UK – 18 November 2019. OGT, A Sysmex Group Company, is proud to announce that its new facility in Cambridge, UK, has achieved Medical Device Single Audit Program (MDSAP) certification of its quality management system (QMS). The announcement further solidifies the company’s aim to reach into molecular diagnostic markets following its first FDA clearance for eight Cytocell Aquarius® Hematology fluorescence in situ hybridization (FISH) probes earlier this year.
Developed by the International Medical Device Regulators Forum (IMDRF), the MDSAP enables medical device manufacturers to fulfill the requirements of multiple participating regulatory authorities through a single QMS audit.
The certification from Lloyd’s Register (LR) is for the full MDSAP scope, which is based on ISO 13485:2016 with additional country-specific requirements for the US FDA, Health Canada, TGA (Australia), ANVISA (Brazil), MHLW and PMDA (Japan).
John Anson, OGT’s CEO said: “This is a major achievement for the company and clearly further demonstrates our commitment to quality on a global level. MDSAP is a challenging process and its achievement represents a huge team effort across all functions. It demonstrates to our customers that we are dedicated to providing the highest quality molecular diagnostic products and this certification will ultimately facilitate future IVD approvals - bringing these products to market faster.”
John Perkins, Cytocell’s QC/QA Manager, said: “MDSAP certification is yet another important milestone for us, following last year’s successful transition to the updated standards, ISO 9001:2015 and ISO 13485:2016. It demonstrates the strength of our quality system and our continued commitment to quality, in fact in October 2019 we will have held ISO certification continuously for 20 years.”
OGT, a Sysmex Group company, is a leading global provider of clinical and diagnostic genomic solutions that are created for scientists by scientists - including CytoCell®, CytoSure® and SureSeq™ ranges of FISH, microarray and NGS products. The company is dedicated to creating products that enable researchers and clinical decision makers to reach the right care decisions for each patient, every time. OGT strives to unlock the future of genetic clinical care with a commitment to working in partnership with its customers - not only by sharing its expertise of 25 years at the forefront of genetic endeavour, but also by working closely with scientists to understand their unique challenges, and to customise its approach to meet their exact needs. Dedicated to improving clinical care, OGT believes that through partnership—together—we’ll achieve more.
For more information on the Company, please visit our website at ogt.com
CytoSure®, SureSeq™ and myProbes®: For Research Use Only, not for use in diagnostic procedures. CytoCell: Some products may not be available in your region.
About Sysmex Corporation
Sysmex Corporation is a world leader in clinical laboratory systemization and solutions, including laboratory diagnostics, laboratory automation and clinical information systems. Serving customers for more than 50 years, Sysmex focuses on technological leadership in diagnostic science and information tools that make a difference in the health of people worldwide. The company is also exploring emerging opportunities in the life science field. Its R&D efforts focus on the development of high-value-added testing and diagnostic technologies that are innovative, original and optimize individual health. Sysmex also seeks to leverage its state-of-the-art technologies for cell, gene and protein analysis. The company, headquartered in Kobe, Japan, has subsidiaries in North America, Latin America, Europe, the Middle East, Africa, China and Asia Pacific and employs more than 9,000 employees worldwide. Sysmex Corporation is listed in the top tier of the Tokyo Stock Exchange.
For more information about Sysmex Corporation and its affiliate companies, please visit www.sysmex.co.jp/en/.
Addition of direct-sales territories follows successes across Europe and APAC and provides customers with enhanced local sales and support services.Read
Paper published in npj Genomic Medicine demonstrates identification of more reportable CNVs with CytoSure v3 vs traditional array design.Read