Hyun-Woo ChoRegulatory Affairs & Quality Management Manager at Konica Minolta Business Solutions
Hyun-Woo works as regulatory affairs (RA) and quality management (QM) manager for medical devices at Konica Minolta Business Solutions Europe. Previous stations are BIOTRONIK, Carl Zeiss Meditec AG and ASAHI INTECC.
He has more than eight years of experience in RA/QM of medical devices, with all types of medical devices from low to high risk and worldwide regulations, e.g. 510(k), De novo, PMA by U.S. FDA, ANVISA in Brazil and PMDA in Japan.
His focus is on the development of international regulatory strategies and the implementation of new regulatory requirements in the organization including the supply chain, e.g. transition from MDD to MDR in Europe.