DaYeon Choi has over 3 years of regulatory experience with in-vitro diagnostic medical devices and provided regulatory strategy and compliance oversight for market approvals. She also has hands-on experience with regulatory submissions for IVD devices in EU and global markets.
As a Quality and Regulatory Affairs Consultant, DaYeon’s expertise focuses on EU IVD Directive/IVD Regulation for CE Marking, compilation of CE Technical Files, and review of EU labelling requirements/technical documentation.