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)
Frequently Asked Questions about Hyunbae Park
What company does Hyunbae Park work for?
Hyunbae Park works for 카카오헬스케어 - Kakaohealthcare
What is Hyunbae Park's role at the current company?
Hyunbae Park's current role is Director.
What schools did Hyunbae Park attend?
Hyunbae Park attended 성균관대학교.
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HyunBae Park
Seoul Incheon Metropolitan Area
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