Oxford Gene Technology (OGT), A Sysmex Group Company, has announced 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 Haematology fluorescence in situ hybridisation (FISH) probes earlier this year.
Developed by the International Medical Device Regulators Forum (IMDRF), the MDSAP enables medical device manufacturers to fulfil 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."