Hyunbae Park Email and Phone Number

Regulatory Affairs and Quality Assurance Specialist - Artificial Intelligence Medical Device, Software as a Medical Device(SaMD)(Jun 2023 ~ ) KakaoHealthcare Corp.- Senior Manager, RA Team Lead- MFDS Approval: U-healthcare gateway software, class 2(PASTA)(May 2022 ~ Jun 2023) Hutom Inc.-(Oct 2022~ Jun 2023)Quality Management Group Leader(RA/QA Team, V&V Team, InfoSec Team)- Sr.RA/QA Manager- MFDS Certifications: Medical image, treatment planning software(RUS, RealSurg), Medical image, analysis software(RUS CREATOR)- IMDRF Software As a Medical Devices WG Participant(DITTA Member)(June 2018 ~ May 2022) VUNO Inc.- Sr. RA/QA Manager - Achievements(1) MFDS Approval & Certification for AI Medical Devices (Medical Imaging, Pathology, Bio-signal)(2) CE Certification for 5 AI Medical Devices (Medical image analyzing software for Bone Age, Chest X-ray, Lung CT, Fundus and Brain image)(3) Managed and maintained the quality management system in accordance with ISO 13485(4) MFDS Breakthrough Medical device designation (VUNO Med-Fundus AI, VUNO Med–DeepCARS)(5) IMDRF Artificial Intelligence Medical Devices Working Group (IMDRF/AIMD WG/N67, Machine Learning-enabled Medical Devices: Key Terms and Definitions)(6) Quality Manager Instructor at National Institute of Medical Device Safety Information (SaMD Good Manufacturing Practice)