PART I. MEDICAL DEVICE REGULATORY SYSTEM
10:00
Opening Speech
Mr. Dae Wook Kang
Seoul BioHub Center, Head, Korea
IMDS for Startups: Program Overview
Ms. Joanne Lee
MediHeroes, CEO
10:05
Global Medical Market:
How to Enter the US Market
Mr. John Hardesky
LiquidSMARTS℠, Head of Commercialization Services, USA
McKesson, Lab Solutions, Former VP, USA
10:40
Regulatory System Overview
and How To Access Different Markets
Mr. Jack Wong
Asia Regulatory Professionals Association, Founder
Nanyang Technology University, Professor, Singapore
11:00
Global Regulatory Strategy for Startups
Ms. May Ng
ARQon(Asia Regulatory Quality Consultancy), CEO
ASEANMed, Co-Chairperson, Singapore
5mins break
11:30
Global Medical Market II:
Medical Device Market in Singapore & its Strategic Importance to enter the ASEAN market
Mr. David Lee
MedtechBOSS, VP of Business Development, Singapore
12:00
Quality Management System & ISO Standards
Mr. Chanyo Won
CT/S Regulatory Consultancy, CEO, Korea
12:30
Conduct Medical Device Clinical Trials
based on ISO14155
Dr. Seung Zhoo Yoon
Korea University Hospital, Professor
Korea University Medical Device Innovation Center, Head
lunch break (60min) 1:00-2:00
PART II. GLOBAL MEDTECH MARKET & TECHNOLOGY
14:30
Government Policy for Medical Device Industry and Support Project of KHIDI
Mr. Taeyoung Youn
Korea Health Industry Development Institute(KHIDI)
Team leader, Korea
15:00
Learn from Fellow MedTech Startups -
Startup Success Story: RIMSCIENCE
Dr. Sang-Jin Yoon
RIMSCIENCE, Ltd., CEO & Founder
& Gachon University-Gil Medical Center, M.D, Korea
15:30
TIPS(Tech Innovator Program for Startups) by Korea Institute of Startup & Entrepreneurship Development(KISED)
Mr. John Changhyung Lee
Korea Institute of Startup & Entrepreneurship Development (KISED) Investment Cooperation Div., General Manager, Korea
5mins break
PART III. RAISING FUNDS & HOW TO PREPARE FOR GLOBAL COMPETITIONS
16:00
Why join a global MedTech competition or accelerator?
Mr. Fredrik Nyberg
Medtech Innovator Asia Pacific, Managing director, USA
16:30
Challenges of developing AI-base algorithms
for Medical Devices
Prof. Wee Ser
Nanyang Technological University, Professor
Space(MedTech) Pte. Ltd, co-founder, Singapore
17:00
Global Medical Device Distribution Channel
Mr. Edgar Kasteel
LuctorMedical BV, Managing Director
EMERGO Group, Co-founder & The Netherland Enterprise Agency, Advisor for Life Science, The Netherlands
17:30
Innovations in the MedTech Industry:
Digital Healthcare and Beyond
Mr. Young Hwan Jung
invites healthcare, Digital Healthcare Division, Head, Korea
17:50
MedFIT Event, 4th edition, Digital in France
Dec 07-15, 2020 (Introduction)
Eurasanté representative, France
18:00 Closing Speech
Disclaimer: IMDS Program details subject to change
*Once you have signed up IMDS, you are agreed for the data usage by MediHeroes, ARPA and ARQon.
FACILITATORS
Joanne J.Lee
이정란 대표, 메디히어로즈 B2B 메디컬 플랫폼
MediHeroes, B2B Medical Platform, Founder
May NG
메이 응, 아시아 인증 & 품질 컨설팅 전문회사 대표
ARQon(Asia Regulatory & Quality Consultancy),
Global Director
Jack wong
잭 왕, 아시아 인증 전문가 협회 설립자
ARPA Founder
(Asia Regulatory Professionals Association),
Six Sigma Black Belt certified by IASSC
EXPERT PANEL
Virginia Chan
지멘스 디지털 소프트웨어 아시아태평양 본부장,
의료기기산업 디지털혁신 담당
Head of Digital Transformation Medical Devices Industry, APAC Siemens Digital Industries Software
Dr. Euiyul Choi
최의열 대표이사, 바디텍메드㈜
Boditech Med, Inc., CEO
Joonyun Kim
김준연 대표, 인바이츠헬스케어
inviteshealthcare Co., ltd., CEO
Kangwook Kim
김강욱 파트너변리사, 특허법인 다해
Patent Attorney & Managing Partner,
DAHAI Patent & Law Firm
Dr. Seungho Yoo
유스바이오 글로벌 대표 &
동국대 의생명공학 겸임교수
YouthBio Global, CEO & Dongguk University,
Adjunct Professor
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CY(Chanyo) Won
원찬요, 씨티앤에스 대표
CTNS & ARQon Korea, CEO
Dr. Seung Zhoo Yoon
윤승주 고대병원 마취과 교수,
고대병원 의료플랫폼상생센터장
Korea University Hospital, Professor,
Dept. of Anesthesiology &
Head of Korea University
Medical Device Innovation Center
(in alphabetical order)
2019년 싱가폴에서 시작된 IMDS (international Medical Device School)은 의료기기 라이프사이클 전반의 핵심 전략과 노하우를 국내외 의료기기 전문가들 (예:유럽 의료기기 유통전문 컨설턴트, 싱가폴 의료 인증 회사 대표, 국내 의료기기 영업 및 마케팅 전문가 등)과 집중으로 탐구하는 과정입니다.
의료기기 라이프사이클 - R&D, 제품설계, 제조, 인증, 임상, 품질관리, 글로벌 의료시장 유통 구조, 해외 진출 방안, 해외 주요 의료기기 박람회 및 컨퍼런스 활용 방안, 최신 기술 트렌드(의료기기와 Digitalization, AI, IoT, IoMT, ICT기술과의 접목 등), 제품 주기 관리 - 기간별 접근 방법과 제품 설계에 대한 새로운 솔루션과 전략 등을 모색하고자 마련된 프로그램입니다.
의료기기산업의 글로벌 네트워킹 플랫폼
ABOUT IMDS KOREA
인터내셔널 메디컬 디바이스 스쿨
2020년에는 싱가폴 이외 한국, 중국, 대만에서 운영되며, 향후 스위스, 독일, 일본, 미국, 중동, 호주 등 전세계적으로 운영됩니다. IMDS Korea 졸업생 및 전문가 패널은 IMDS Global Alumni Network을 통해 전세계 의료기기 관계자들과 교류하고, 글로벌 네트워킹을 확장해나갈 수 있을 것입니다.
수강대상: 의료기기 다국적기업 CEO, 스타트업 종사자, 의료기기 제조업체, 유통업체, 임상 및 인증 전문가, 의료 관련 전문가, R&D 연구개발자, 의료기기 영업 전문가, 의사, 의료기기 관련 전공 학생 및 관심자 등
IMDS KOREA 등록 문의는 edu@mediheroes.com또는
02-6406-3838로 연락주십시오.
A Truly Global Networking Channel with MedTech Professionals Worldwide
About
IMDS
Certificate
Program
The International Medical Device School was successfully launched with a comprehensive 4-day syllabus featuring over 50 speakers in October, 2019 in Singapore and will be rolling out internationally in countries such as Korea, China, Taiwan, Malaysia, Switzerland, Germany, Japan, USA, Thailand, India.
MediHeroes, together with ARQon (Asia Regulatory & Quality Consultancy) and ARPA (Asia Regulatory Professional Association) is launching International Medical Device School in Korea for MEDTECH INDUSTRY PROFESSIONALS to gain a comprehensive overview of medical devices lifecycle, from research and development stages to commercialization.
The program details in Singapore can be found in the link below.
https://www.medtechboss.com/imds
Who should attend?
Medtech companies’ Management, CEO, Investor, Start-up, MNC, Manufacturer, Distributor, Regulatory, Government Affairs, Quality, R&D Engineer, Legal, Clinical, Marketing and Sales professionals.
An IMDS KOREA Program will be launched on Dec. 08, 2020. To learn more about IMDS Korea, please email us at edu@mediheroes.com.
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Gain valuable insights and experiences from the key respected speakers in the field to apply to your work/decision and preventing common mistakes.
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Gain a comprehensive understanding on global regulatory landscape and latest updates including the new CE MDR/IVDR enforcement by May 2020/2022.
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Discover the design, testing and standards requirements for product safety.
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To explore the advanced technologies in medical device.
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To hear about the market strategies, opportunities and challenges in the manufacturing and distribution. Networking with Medtech partners and industries, for potential collaboration.
Key Benefits
Community Partners
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Association for the Advancement of Medical Instrumentation (AAMI)
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Asia Regulatory and Professional Association (ARPA)
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Agency for Science, Technology and Research (A*STAR) Singapore Biodesign
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Biomedical Engineering Society (BES), Singapore
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British Standards Institution (BSI)
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European Enterprise Network (EEN)
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Informa Knect365 Medical Device Training International (MDTI Online training)
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Institute of Engineers, Singapore (IES) Biomedical Engineering Technical Committee
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Industrial Technology Research Institute (ITRI), Taiwan Republic of China
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Intellectual Property Intermediary (IPI)
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Jurong Town Corporation (JTC)
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National Healthcare Innovation Centre (NHIC)
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NUS Enterprise
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SGInnovate
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Singapore Manufacturing Federation’s MedTech Industry Group (SMF’s MTIG)
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Singapore Manufacturing Federation’s Standard Development Organization (SMF’s SDO)
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Singapore Manufacturing Federation’s GS1 (SMF’s GS1)
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TUV Rheinland
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TUV SUD
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Underwriters Laboratories (UL)
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National Additive Manufacturing Innovation Cluster (NAMIC)
Organisers:
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