HDX WILL Co,.Ltd (Medical device) - Production Management - Education Buyer - KGMP Participation and assistance for approval review - FDA Participation and assistance for approval review - CE MDD Participation and assistance for approval reviewMEDITULIP Co,.Ltd (Medical device) - Regulatory Affairs - Initial establishment of a medical device factory, based on ISO 13485. - Class 4 medical device MFDS approval completed, - Class 4 medical device MFDS component change approval completed(Communication with business partners regarding pointed matters) - BSI sterilization product-related screening and audit completed (English)Z Biotech Co..Ltd (IVD) - Regulatory Affairs / Quality Assurance - Covid-19 antigen diagnostic kit CE Approved - Covid-19 antigen diagnostic kit KFDA Approved - Covid-19 antigen diagnostic kit TGA approval in progress - Covid-19 antigen diagnostic kit WHO approval in progress - Covid-19 antigen diagnostic kit FDA approval in progressVPIX Medical Co.,Ltd - Regulatory Affairs / Quality Assurance - CE IVDR Class A aproved (Main : Preparation of clinical evaluation report) - FDA Class I listing - Initial establishment of a medical device factory, based on ISO 13485. MMILR Inc. - Regulatory Affairs / Quality Assurance Team Leader / Quality Manager - GMP facility establishment - Establishment of procedures in accordance with ISO 13485 regulations. - BSI ISO 13485 auditor training course completion