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KIMES Seminar

3/24(Fri)
  • 1
    Cybersecurity in Medical Device

    [Speaker ] TUV Rheinland | TUV Rheinland | Shotaro Kaida | Head of Cybersecurity Service in Asia Pacific

    • [Date] 3.24(Fri) (10:00~12:00)
    • [Organizer] Korea Medical Devices Industrial Cooperation Association
    • [Venue] Rm. 317
    • [Contact] +82-70-4837-5579
  • 2
    CE IVDR Regulation

    [Speaker ] TUV Rheinland / Yu, Ji Gu / IVD Product Specialist

    • [Date] 3.24(Fri) (14:00~18:00)
    • [Organizer] Korea Medical Devices Industrial Cooperation Association
    • [Venue] Rm. 317
    • [Contact] +82-70-4837-5579
  • 3
    Person Responsible for Regulatory Compliance(PRRC)

    [Speaker ] DNV SOO HYUK UHM Lead Auditor

    • [Date] 3.24(Fri) (09:00~18:00)
    • [Organizer] Korea Medical Devices Industrial Cooperation Association
    • [Venue] Rm. 318
    • [Contact] +82-70-8892-3740
  • 4
    Open Innovation: Partnership for Global Marketing of Korean Medical Devices
    • [Date] 3.24(Fri) (10:30~11:30)
    • [Organizer] KMDIA
    • [Venue] Rm. 307
    • [Contact] +82-70-7725-8136
Welcoming Remarks [Speaker ] KMDIA Cheolwook Yoo Chairman [Time] 10:30~10:35
Strategies and Experiences on Open Innovation Shared by Multi-National Medical Device Companies in Korea [Speaker ] B.Braun Korea Sunghyun Yoo Marketing Manager [Time] 10:35~10:45
Strategies and Experiences on Open Innovation Shared by Multi-National Medical Device Companies in Korea [Speaker ] J&J Medical Korea Eunha Kim Head of Strategy & Innovation, North Asia [Time] 10:45~10:55
Turbocharging Collaboration in Open Innovation  [Speaker ] APACMed Gabriel Sim Director,Strategic Partnership [Time] 10:55~11:05
Perspectives and Challenges on Entering into Global Market from Local Business View [Moderator] CEO Hyun-Jun Kim, Vyte
[Speaker ] B.Braun Korea Changhyung Chae Managing Director J&J Medical Korea Jinyong Oh North Asia Area Managing Director T&R Biofab Wonsoo Yun CEO STARmed Henry Shin CEO		 [Time] 11:05~11:30
  • 5
    Seminar for the competitiveness in export with medical equipment industry
    • [Date] 3.24(Fri) (13:00~15:50)
    • [Organizer] Seoul Regional Customs
    • [Venue] Rm. 307
    • [Contact] +82-70-7725-6999
Export Declaration Guide [Speaker ] Seoul Regional Customs / Heo Hun / Manager [Time] 13:00~13:20
The effective utilization of FTA in medical appliance industry [Speaker ] Seoul Regional Customs / Lim eun ju / Manager [Time] 13:30~14:00
Seoul regional customs: Support Business Guide for export enterprise - Supporting program for export-import enterprise
- Addressing potential challenges in overseas customs clearance		 [Speaker ] Seoul Regional Customs / Kim Kyung Ah / Manager [Time] 14:00~14:20
Seoul Business Agency’s export support programs for SMEs in 2023 [Speaker ] SBA / Shin Woojin / Assistant Maganer [Time] 14:30~14:50
K-SURE Support Business Guide -Utilization Of Trade Insurance And Export Credit Guarantee [Speaker ] K-SURE / Lee Mu-Hong / Assistant Manager [Time] 15:00~15:30
K-SURE Support Business Guide -Management Method Of Oversea Bond [Speaker ] K-SURE / Kim Dae-Hyun / Manager [Time] 15:30~15:50
  • 6
    Seminar for Strengthening Sound Ethical Management Activities in Medical Devices
    • [Date] 3.24(Fri) (14:00~16:40)
    • [Organizer] KMDIA
    • [Venue] Rm. 402
    • [Contact] +82-2-596-6381
Policy Trends Related to Medical Device Sales Order [Speaker ] Ministry of Health and Welfare / Jung Hyun Yeo / deputy director [Time] 14:00~14:40
A Survey on Medical Device Expenditure Report [Speaker ] Health Insurance Review and Assessment Service / Mi sun Ahn / Team leader [Time] 14:40~15:10
Expected dispute issues and countermeasures after the disclosure of the expenditure report [Speaker ] Kim & Chang law firm / lawyer [Time] 15:20~16:00
Countermeasures for investigation by investigative agencies according to rebate issues [Speaker ] SHIN & KIM LLC / lawyer [Time] 16:00~16:40
  • 7
    Digital Healthcare Seminar on Medical Device
    • [Date] 3.24(Fri) (10:20~17:30)
    • [Organizer] WONJU MEDICAL INDUSTRY TECHNOVALLEY
    • [Venue] Rm. 300
    • [Contact] +82-33-760-6136
Trends in the Digital Healthcare Industry [Speaker ] CHUNGBUK NATIONAL UNIVERSITY / Young-Jun, Song / Professor [Time] 10:20~11:10
An example of a healthcare startup company [Speaker ] MMIL-R / Jin-Hui, Moon / CEO [Time] 11:20~12:10
Commercialization Guidelines for Biometric Data Collection System [Speaker ] KPMG Samjong Accounting Corp. / Yu-Jin, Choi / Executive Officer [Time] 14:00~14:50
Patent Strategy for Digital Healthcare [Speaker ]WIPS Co.,Ltd / Sang-Deok, Lee / Senior Researcher [Time] 15:00~15:50
Galaxy Watch’s health function and biometric data use cases [Speaker ] SAMSUNG 박원호, 이성철 Pro [Time] 16:00~17:30
  • 8
    디지털치료기기 산업 활성화를 위한 기술세미나
    • [Date] 3.24(Fri) (13:00~17:30)
    • [Organizer] (재)강원테크노파크
    • [Venue] 301호
    • [Contact] +82-70-4269-6332
디지털치료기기 개발지원 현황 및 사업화 촉진을 위한 추진 세부 계획 [Speaker ] 한국산업기술 평가관리원 박지훈 PD [Time] 13:45~14:35
국내외 개발 사례를 중심으로한 디지털치료기기 인허가 방향 및 개발 전략 수립 방안 [Speaker ] 식품의약품안전처 한영민 주무관 [Time] 14:35~15:25
글로벌 디지털치료기기 산업 동향을 통한 국내 기업 대응 전략 방안 [Speaker ] 원주세브란스기독병원 박성빈 교수 [Time] 15:35~16:25
소프트웨어형 의료기기 임상시험 프로세스 및 사례 소개 [Speaker ] ㈜메쥬 김이웅 부사장 [Time] 16:25~17:15
디지털치료기기 개발지원센터 소개 및 기업지원 프로그램 안내, 세미나 마무리 [Speaker ] (재)강원테크노파크 김민호 팀장 [Time] 17:15~17:30
  • 9
    글로벌 표준 기반 ICT 융합 의료기기 대응 전략 국제세미나
    • [Date] 3.24(Fri) (14:00~17:30)
    • [Organizer] 한국스마트의료기기산업진흥재단
    • [Venue] 308호
    • [Contact] +82-2-6347-5104
스마트의료기기 산업 동향 및 표준화 전략 [Speaker ] (재)한국스마트의료기기산업진흥재단 허영 부이사장 [Time] 14:00~14:30
ICT 융합 의료기기 정보보안의 중요성 및 관련 표준 소개 - ICT 사이버보안 안전 규격 UL2900 등 [Speaker ] Intertek, Connected World | Paula Peng | BD Manager [Time] 14:30~15:30
중국 ICT 융합 의료기기 인허가 대응 전략 및 적용 표준 [Speaker ] CIRS Group | Cindy Fu（傅赛珍）| Deputy General Manager(副总经理) [Time] 15:30~16:30
유럽 ICT 융합 의료기기 인허가 대응 전략 및 적용 표준 [Speaker ] 메디가이드 원찬요 대표 [Time] 16:30~17:30
  • 10
    Executive Meeting of Korea Hospital Purchasing Logistics Association
    • [Date] 3.24(Fri) (14:00~16:00)
    • [Organizer] Korea Hospital Purchasing Logistics Association
    • [Venue] Rm. 320
  • 11
    The latest trends in medical device sterilization and quality control.
    • [Date] 3.24(Fri) (14:00~17:00)
    • [Organizer] Greenpiatechnology Inc.
    • [Venue] Rm. 327
    • [Contact] ockwon@greenpiatech.com
The latest trend in medical device sterilization / Process control of radiation sterilization [Speaker ]Greenpiatechnology Inc. / Young-woon EOM / Senior Researcher [Time] 14:00~14:40
The quality control of contract sterilization [Speaker ] Synex Consulting Ltd. / Hye-jeoung Lee / Sr. Project Manager [Time] 14:50~15:30
The Microbiology Testing of Medical device [Speaker ] Greenpiatechnology Inc. / Hoo-chul LEE / Senior Researcher [Time] 15:40~16:20
The meeting for medical device sterilization [Speaker ] Greenpiatechnology Inc. / Sang-chul KIM / Principal Researcher [Time] 16:30~17:00
  • 12
    MZ세대 의공사 SEMINAR 2023
    • [Date] 3.24(Fri) (10:00~12:20)
    • [Organizer] 가톨릭대학교 은평성모병원 외
    • [Venue] 328호
    • [Contact] 카톨릭대학교 은평성모병원, 송재훈 팀장 (010-5222-9140)
90년대생 의공사 관점으로 본 차세대 의공사 발전방향 [Speaker ] 건국대학교병원 손보경 [Time] 10:00~10:20
임상현장 기반의 의료기기 및 연구기기 개발제작 적용사례 공유 [Speaker ] 국립암센터 이주환 [Time] 10:20~10:40
병원 안전사고 예방활동 및 의약품 주입펌프 risk management [Speaker ] 가톨릭대학교 은평성모병원 김경태, 신동욱 [Time] 10:40~11:00
병원 스마트 의료기술의 발전방향 [Speaker ] 성남시의료원 임진성 [Time] 11:00~11:20
RRS 모니터링 구축 및 3D printer 적용사례 공유 [Speaker ] 용인세브란스병원 정준영 [Time] 11:20~11:40
병원 내 안전사고 예방활동 사례 공유 [Speaker ] 명지병원 구본민 [Time] 11:40~12:00
3D printer를 활용한 의료기기 수리사례 공유 [Speaker ] 양산부산대학교병원 윤성욱 [Time] 12:00~12:20
  • 13
    대한민국, 멸균의 미래 (앞으로 10년 후)
    • [Date] 3.24(Fri) (14:00~17:00)
    • [Organizer] 챔버, SteelCo Korea
    • [Venue] 328호
    • [Contact] 031-357-7473
멸균 통합관리시스템 : 추적에서 관리까지 [Speaker ] ㈜챔버 송 혁 CEO [Time] 14:00~14:50
멸균기의 미래와 정확한 모니터링의 방향 [Speaker ] ㈜챔버 송 혁 CEO [Time] 15:00~15:50
중앙공급실 세척과 멸균의 기본및 최신경향 [Speaker ] Steelco Korea 이영근 지사장 [Time] 16:00~17:00
  • 14
    Medical Device EU MDR, FDA 510(k) Registration Strategy & Clinical Trial Plan
    • [Date] 3.24(Fri) (9:00~18:00)
    • [Organizer] KBIO Solutions
    • [Venue] Rm. 403
    • [Contact] +82-70-4293-7075
Medical Device Global Market Analysis, MDR & 510(k) Key Requirements [Speaker ] KBIO Solutions / Kyungyoon Kang / CEO [Time] 09:00~10:00
FDA 510(k) Substantial Equivalence, Performance & Safety Testing Strategy [Speaker ] KBIO Solutions / Kyungyoon Kang / CEO [Time] 10:10~11:00
KGMP/Quality System Management Documentation [Speaker ] KBIO Solutions/ Jeongeun Park, Mikael Hellstrand / Manager [Time] 11:10~11:30
MDR CE, FDA 510(k), GMP Q&A Session [Speaker ] KBIO Solutions / Kyungyoon Kang / CEO [Time] 11:30~12:00
EU MDR Documentation Practice [Speaker ] KBIO Solutions / Jian Park, Brandon Green / Manager [Time] 13:00~13:20
MDR Documentation-Tech Doc, GSPR, Risk Management, PMS, IFU [Speaker ] KBIO Solutions / Kyungyoon Kang / CEO [Time] 13:20~14:00
EU MDR 2017/745 MDCG Guidance Review [Speaker ] KBIO Solutions / Yujin Ahn / Senior Manager [Time] 14:10~15:00
How to Write MDR Clinical Evaluation Report and PMCF Report [Speaker ] KBIO Solutions / Kyungyoon Kang / CEO [Time] 15:10~16:00
Medical Device-Clinical Study Development Strategy [Speaker ] KBIO Solutions / Kyungyoon Kang / CEO [Time] 16:10~17:10
Q&A Session for EU MDR, FDA 510(k), Clinical Study Development [Speaker ] KBIO Solutions / Kyungyoon Kang / CEO [Time] 17:15~18:00
  • 15
    2023 범부처 규제대응 전담데스크 활성화 협의체
    • [Date] 3.24(Fri) (14:00~17:00)
    • [Organizer] 식품의약품안전처, 범부처전주기의료기기연구개발사업단, 대구경북첨단의료산업진흥재단
    • [Venue] 304호
2023 범부처 규제대응 전담데스크 활성화 협의체 - [Time] 14:00~17:00
  • 16
    EU Regulations for Medical Devices and Clinical Studies as per IVDR/MDR

    [Speaker ] Requalite GmbH | Dr Hakan Inan | Managing Director

    • [Date] 3.24(Fri) (11:00~12:00)
    • [Organizer] Requalite GmbH
    • [Venue] Rm. 315
    • [Contact] hakan@requalite.com
  • 17
    The future of sterilization (10 years)
    • [Date] 3.24(Fri) (10:00~12:00)
    • [Organizer] Chamber INC.
    • [Venue] Rm. 328
    • [Contact] 031-357-7473
MZ세대 의공사 SEMINAR 2023 [Speaker ] (카)은평성모병원 Song Jae Hoon & [Time] 10:00~12:00
Integrated Sterilization Management System [Speaker ] Chamber INC. / Song Hyeok / CEO [Time] 13:00~13:50
The Future of Sterilizers and the Direction of Accurate Monitoring [Speaker ] Chamber INC. / Song Hyeok / CEO [Time] 14:00~14:50
Basic and New Trends in Washer disinfection and Sterilization of CSR [Speaker ] Steelco Korea Lee Yeong Guen Steelco Korea Country Manager [Time] 15:00~15:50