OGT continues move into molecular diagnostics markets with MDSAP certification

Nov. 21, 2019

Oxford Gene Technology (OGT), A Sysmex Group Company, 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 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). 

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