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Seminar Schedule

March 14th
  • 1
    Korea-Brazil International Cooperation Seminar on Orthopedic Medical Device Technology and Standard Trends
    • [일시] 03월 14일 (10:10-12:10)
    • [주관] Medical Device Industry Promotion Foundation
    • [장소] 308
    • [문의] +82-2-6347-5104
Recent Technological Advances in Orthopedic Implants and Standard Trends in Artificial Joints [강사] Corentec | Kim Jung sung | vice-president [시간] 10:10-10:40
Osteosynthesys and Spine Implants: technological trends and associated standardization on ISO TC150/SC5 [강사] Federal University of Santa Catarina (UFSC) | Carlos Rodrigo de Mello Roesler | ISO TC 150/SC5/WG1 Convenor [시간] 10:40-11:10
Recent technological advances and standard trends in stent delivery system [강사] Dong-A Pharmaceutical | Jang Bong Seok | Lead Manager [시간] 11:10-11:40
Materials for Implants: current concepts, trends and associated standardization on ISO TC150/SC1 [강사] National Institute of Metrology | Rafael Mello Trommer | Chair of ABNT Technical Committee [시간] 11:40-12:10
  • 2
    3rd General Meeting of the Smart Medical Device Win-Win Forum
    • [일시] 03월 14일 (13:30-14:30)
    • [주관] Smart Medical Device Win Win Forum
    • [장소] 308
    • [문의] +82-2-6347-5000
  • 3
    Hospital-Business Win-Win Cooperation Strategy for Global Exports
    • [일시] 03월 14일 (14:30-16:50)
    • [주관] Smart Medical Device Win Win Forum
    • [장소] 308
    • [문의] +82-2-6347-5000
  • 4
    Revolution in Hair Damages Repair: How CG-Follicare Repairs Physical & Chemical Damages in 5 min?
    • [일시] 03월 14일 (10:30-16:00)
    • [주관] Caregen Co., Ltd.
    • [장소] 310
    • [문의] +82-32-420-9212
Revolution in Hair Damages Repair: How CG-Follicare Repairs Physical & Chemical Damages in 5 min? [강사] Caregen | Yongji Chung | CEO [시간] 10:30-11:30
Revolution in Hair Damages Repair: How CG-Follicare Repairs Physical & Chemical Damages in 5 min? [강사] Caregen | Yongji Chung | CEO [시간] 15:00-16:00
  • 5
    China Medical Device Testing and NMPA Registration
    • [일시] 03월 14일 (14:30-16:30)
    • [주관] China Medical Device Testing and NMPA Registration
    • [장소] 311
    • [문의] +82-31-455-1868
China Medical Device Testing and NMPA Registration [강사] GRG TEST | Mr. Zheng Yi | Medical Lab Director [시간] 14:30-16:30
  • 6
    Medical Device MDR, FDA 510(k) Registration Strategy & Clinical Study Plan
    • [일시] 03월 14일 (09:30-18:00)
    • [주관] KBIO Solutions
    • [장소] 328
    • [문의] +82-2+597+2700
Medical Device Global Market Analysis, MDR & 510(k) Key Requirements [강사] KBIO Solutions Kyungyoon Kang CEO [시간] 09:30-10:30
FDA 510(k) Substantial Equivalence, Performance & Safety Testing Strategy [강사] KBIO Solutions Kyungyoon Kang CEO [시간] 10:45-11:30
MDR CE, FDA 510(k), Q&A Session [강사] KBIO Solutions Kyungyoon Kang CEO [시간] 11:30-12:00
Preparing Methods for FDA 510(k) eSTAR Files [강사] KBIO Solutions [시간] 13:10-14:00
EU MDR 2017/745 MDCG Guidance Review [강사] KBIO Solutions [시간] 14:10-15:00
How to Write MDR CER, Clinical Study Development [강사] KBIO Solutions Kyungyoon Kang CEO [시간] 15:10-16:00
MDR Documentation-Tech Doc, GSPR, Risk Management [강사] KBIO Solutions Kyungyoon Kang CEO [시간] 16:10-17:00
Q&A Session for EU MDR, FDA 510(k), [강사] KBIO Solutions Kyungyoon Kang CEO [시간] 17:10-18:00
  • 7
    CE IVDR Technical File and Clinical Evidance
    • [일시] 03월 14일 (14:00-17:30)
    • [주관] Korea Medical Devices Association
    • [장소] 317
    • [문의] +82-70-4837-2793
Introduction of CE IVDR and Clinical Evidance [강사] TUV Rheinald Korea | Ji-Gu, Yu | Lead Auditor [시간] 14:00-15:40
CE IVDR Performance Studies and Technical Document [강사] TUV Rheinald Korea | Ji-Gu, Yu | Lead Auditor [시간] 16:00-17:30
  • 8
    Cybersecurity in Medical Device

    TUV Rheinland Japan | Kaida Shotaro | Senior Expert

    • [일시] 03월 14일 (10:00-12:00)
    • [주관] Korea Medical Devices Association
    • [장소] 317
    • [문의] +82-70-4837-2793
Cybersecurity in Medical Device [강사] TUV Rheinland Japan | Kaida Shotaro | Senior Expert [시간] 10:00-12:00
  • 9
    In Silico Technology in Medical Device
    • [일시] 03월 14일 (09:30-12:15)
    • [주관] Korea Medical Devices Association
    • [장소] 318
    • [문의] +82-70-4837-2793
Development and demonstration of health data distribution platform for supporting medical device companies based on data curation [강사] CHA University industry academic cooperation foundation | Myung-gwan Kim | Academic Research Professor [시간] 09:30-09:45
Overview of In Silico Technology to Accelerate Product Development and Regulatory Review [강사] Ansys Inc. | Marc Horner | Distinguished Engineer [시간] 09:45-10:15
Research on a Digital Evaluation System for Medical Devices based on Computational Modeling and Simulation [강사] Biomedical Engineering Research Center, Asan Medical Center | JaeSoon Choi | Director [시간] 10:15-10:45
Biomechanical Flow Analysis in Cardiovascular Disease Modeling Utilizing AI Segmentation of Medical Imaging Data [강사] Medical IP | DoeYoung Hur | Principal Investigator [시간] 10:45-11:15
A Case Study on the Development and Commercialization Support of a Medical Device Using In Silico Technology [강사] KBIOHEALTH | YoungJin Kim | Principal Researcher [시간] 11:15-11:45
Safety and Preliminary Performance Evaluation of High-frequency Medical Devices Using Electromagnetic Analysis with Simulation [강사] TaeSung S&E | HyeRyung Na | Technical Fellow [시간] 11:45-12:15
  • 10
    SAMD PRODUCT DEVELOPMENT: ADDRESSING CHALLENGES THROUGH EARLY INTEGRATION OF REGULATORY, QUALITY AND CLINICAL DATA STRATEGIES
    • [일시] 03월 14일 (14:00-17:20)
    • [주관] Korea Medical Devices Association
    • [장소] 318
    • [문의] +82-70-4837-2793
Common steps for bringing a clinical stage AI/ML SaMD product to market / Regulatory Process Planning (Early integration) [강사] NAMSA | MONICA R. MONTANEZ | Principal Strategy Consultant, REGULATORY [시간] 14:00-15:40
Quality System Development & Software Validation Reporting [강사] NAMSA | MONICA R. MONTANEZ | Principal Strategy Consultant, REGULATORY [시간] 16:00-16:40
FDA Draft Guidance on Artificial Intelligence / Machine Learning Enabled Device Software Functions & Predetermined Change Control Plans (PCCP’S) [강사] NAMSA | MONICA R. MONTANEZ | Principal Strategy Consultant, REGULATORY [시간] 16:40-17:20
  • 11
    Strategies for entering the medical device markets in Vietnam and Indonesia
    • [일시] 03월 14일 (10:00-11:50)
    • [주관] Korea Medical Devices Association
    • [장소] 320
    • [문의] +82-70-4837-2793
Strategies for entering the medical device market in Indonesia [강사] Korea Medical Device Association | Shin Songo | Indonesia Center [시간] 10:00-10:50
Strategies for entering the medical device market in Vietnam [강사] Korea Medical Device Association | Kim Yongseob | Vietnam Center [시간] 11:00-11:50
  • 12
    Understanding of Listing Treatment Materials Insurance Benefits
    • [일시] 03월 14일 (15:30-17:00)
    • [주관] Korea Medical Devices Association
    • [장소] 320
    • [문의] +82-70-4837-2793
Understanding of Listing Treatment Materials Insurance Benefits [강사] Health Insurance Review & Assessment Service | Managing Director [시간] 15:30-17:00
  • 13
    [K-Medical Devices] Landmark Achievement of Digital Medical Products & clinical adoption in Korea
    • [일시] 03월 14일 (10:05-11:40)
    • [주관] KMDIA
    • [장소] 307
    • [문의] +82-2-596-0460
Introduction of support project for localization of Digital Medical Products [강사] KHIDI | Sung-Eun, Hwang | Director, Department of Medical Devices & Cosmetics Industry [시간] 10:05-10:25
Introduction to Localization of Digital Medical Products in Hospitals [강사] Yonsei University Health System | Lim Joonseok | Chief Intelligence Officer, Division of Digital Health [시간] 10:25-10:45
Vital AI SaMD in development, and clinical adoption [강사] AITRICS | Byung Eun (Ben) Ahn | CSO [시간] 10:45-11:05
Landmark Achievement : Development of the First Medical Image-Based Digital Brain Surgery Robot System in Korea [강사] KOH YOUNG TECHNOLOGY, INC. | Hyun won ho | medical sales Team leader [시간] 11:05-11:25
Discussion and Q&A [시간] 11:25-11:40
  • 14
    Regulatory trends related to global medical devices
    • [일시] 03월 14일 (09:40-11:50)
    • [주관] CIRS/ Lifang/ Third Party/ KMDIA
    • [장소] 327
    • [문의] +82-70-7725-6999
Medical device clinical trials in China [강사] CIRS Group Korea Yoon Kyu Chi [시간] 09:40-10:30
FDA Third Party Review Program [강사] FDA Third Party Review Group | Taeri Im [시간] 10:35-10:55
IP infringement countermeasures in Chinese Market [강사] Lifang Argus | Yim Dong Sook | President [시간] 11:00-11:50
  • 15
    The Effect of Chemotherapy on the Quality of Life of Breast Cancer Patients and Latest Treatment Trends
    • [일시] 03월 14일 (14:10-16:00)
    • [주관] Humost Nokwon/ KMDIA
    • [장소] 327
    • [문의] +82-2-573-8131
Improving the Quality of Life for Breast Cancer Patients Undergoing Chemotherapy [강사] Cancer Education Division of the Samsung Medical Center | Juhee Cho | Head of Center [시간] 14:10-14:35
Effectiveness of Cooling Cap to Prevent Permanent Chemotherapy-Induced Alopecia among Breast Cancer Patients : A Randomized Controlled Trial [강사] Center for Clinical Epidemiology of the Samsung Medical Center | Danbee Kang | Professor [시간] 14:35-15:00
Panel Discussion [시간] 15:00-16:00
  • 16
    European certification response seminar
    • [일시] 03월 14일 (09:30-11:00)
    • [주관] Korea Medical Devices Association
    • [장소] 301
    • [문의] +82-70-4837-2793
Instruction of the Medical Devices Project [강사] KMDA | JUNG CHULWOO | Manager [시간] 09:30-10:00
European Certification Correspondence Seminar [강사] CJP MediBio Gmb | Dr. LIM YOUNG SUNG [시간] 10:00-11:00
  • 17
    Medical Devices Market Outlook of China
    • [일시] 월 일 (13:30-16:50)
    • [주관] Korea Medical Devices Association
    • [장소] 301
    • [문의] +82-70-4837-2793
Analysis of China ME Industry's Market [강사] Reed Sinopharm Exhibitions Co.,Ltd.| Song Chen | Assistant Project Manager [시간] 13:30-14:30
Overview of Medical Device Regulations [강사] SINOSEOUL CO.,LTD. | Choi Eun Ha | General Manager [시간] 14:40-16:50