Jason Le, Vice President, Quality Assurance and Regulatory Affairs, joined ThermoGenesis in 2012. Jason brings over 26 years of experience in Quality Assurance from start up to established worldwide companies including Medtronic, Hologic. Jason developed and manages all aspects of the Quality Management System that are in compliance with QSR 21 CFR 820, QSR 21 CFR 1217, ISO 13485:2016, MDSAP and transitioning to EUMDR. He leads all FDA, ISO, notified body, supplier, internal and customer audits. Jason’s lends his expertise in Quality Management and Regulatory Affairs to new product development projects and successful management of post market customer feedback programs.