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KIMES Seminar
3/24(Fri)
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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
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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
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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
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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 |
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[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 |
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[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 |
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[Time] 11:05~11:30 |
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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 |
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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 |
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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 |
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[Time] 14:00~14:50 |
Patent Strategy for Digital Healthcare |
[Speaker ]WIPS Co.,Ltd / Sang-Deok, Lee / Senior Researcher |
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[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 |
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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 |
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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 |
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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
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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 |
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[Time] 15:40~16:20 |
The meeting for medical device sterilization |
[Speaker ] Greenpiatechnology Inc. / Sang-chul KIM / Principal Researcher |
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[Time] 16:30~17:00 |
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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 |
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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 |
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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 |
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[Time] 09:00~10:00 |
FDA 510(k) Substantial Equivalence, Performance & Safety Testing Strategy |
[Speaker ] KBIO Solutions / Kyungyoon Kang / CEO |
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[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 |
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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 |
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![]() | [Time] 14:00~17:00 |
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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
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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 & |
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[Time] 10:00~12:00 |
Integrated Sterilization Management System |
[Speaker ] Chamber INC. / Song Hyeok / CEO |
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[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 |