Keynote Hungarian and Romanian Market
Health insurance systems in Hungary and Romania, their respective state subsidy systems, Medical Device (MD) markets and regulatory
The European Union's Medical Device Regulation (EU-MDR) and Hungary's competitive advantages in providing medical device certification services for the European Single Market
The economic potential in these markets, in the field of Medical Devices for Taiwanese enterprise
Keynote Singapore/Malaysia Market
Market Overview and Emerging Trends in Malaysia and Singapore
Dive into the evolving healthcare landscapes, highlighting the current focus areas and digital trends shaping the region’s healthcare sector.
Market Entry Challenges
Address key challenges for digital health solutions, including regulatory hurdles and market-specific dynamics, with strategies for successful go-to-market.
Showcasing Success Stories of Integrated Solutions
Highlight successful integrations and partnerships, demonstrating Qmed Asia’s role in enhancing healthcare delivery and patient outcomes in Malaysia and Singapore.
Mr. Daniel Kapusy
Partner MDR-Cert Initiative (Hungary - Austria), Celonis Value Assessment Expert, Vialto Consulting Ltd. (EU)
Mr. Daniel Kapusy, MSE, MBA, holds the position of Senior Consultant and Expert in Process Mining Value Assessment at Vialto Consulting Ltd. He is also a distinguished founding partner of the MDR-Cert Initiative, a specialized consortium leveraging Hungary's strategic positioning in Central Europe to offer comprehensive Medical Device certification services for the European Economic Area. This initiative uniquely positions itself by facilitating access to the 26 other EU countries, ensuring certifications are recognized across all EU and EFTA nations.
Boasting an impressive tenure of over 30 years in domestic and 20+ years within the EU market, Mr. Kapusy specializes in aiding international firms in launching their innovative medical products within Europe. His expertise encompasses regulatory and compliance consulting, specifically in Medical Device Regulation (MDR), alongside offering CE marking and representative services to streamline the approval process for Medical Devices (MD) in the EU.
As an integral part of the MDR-Cert's quartet of experts, he delivers pivotal consulting services for the introduction of MDs into the EU market, aligning with the recent comprehensive overhaul from the Medical Device Directive 93/42/EEC to the Medical Device Regulation 2017/745/EC.
Within the MDR-Cert Initiative's expert cadre, Mr. Kapusy serves as an advisor to the National Professional Association of Distributors of MD's board (notably FESZ, the esteemed Hungarian Medical Devices Trade Association established in 1995), focusing on MedTech and HealthTec sectors. In this advisory role, Mr. Kapusy champions the adoption of cutting-edge AI technologies to enhance operational efficiencies, diminish healthcare expenditures, and automate critical processes in modern healthcare. Using process automation and Process Intelligence, they help healthcare providers accomplishing common healthcare goals with speed and accuracy.
Leaning on FESZ resources, Mr. Kapusy expertise extends beyond providing EU-MDR certification services to Taiwanese manufacturers, as he can also play a pivotal role in connecting them with key Hungarian MD and Health Equipment importers for seamless EU market entry.
Mr. Kapusy's academic credentials include an MSc in Engineering from the University of Technical Sciences Iasi (Romania) and an MBA from the Central European University (CEU), Budapest/Vienna. His educational journey also took him to the University of Calgary (Canada), where he pursued Materials Science and Engineering, complemented by various professional development programs in Public Procurement Investment Projects, legislative aspects, and EU regulatory and compliance matters.
Furthermore, Mr. Kapusy is certified in personnel security clearance by the National Office of Classified Information (ORNISS), adhering to the rigorous GD-353/2002 standards for the protection of classified information, in line with NATO's stringent security protocols.
Mr. Kazuya Hijii
CEO, mk DUO LLC
Area of Expertise：
QMS, Medical device regulation for Japan/ Europe/ USA/ Asian countries, Medical device standards for Electrical Safety/ EMC/ Software Life Cycle/ Risk Management/ Usability/ Clinical evaluation/Statistical techniques
Major Experience：
1998 - 2007:
- Developed active medical devices for treatment as mechanical and software engineer.
- Conducted market research for new medical devices all over the world
- Registered medical devices based on Japan, European, US and Asian countries medical device regulations.
- Conducted and passed tests required by various standards for medical devices
2007 - 2020:
- Assessed medical device dossier under Japan and overseas regulation
- Conducted QMS audit based on ISO13485, Medical device QMS standard
- Provided seminars and trainings regarding Medical device regulation and standards
2020 - :
- Provided consultation service to whom wants to go into medical device business
Mr. Hua Phu Doan
Vice Chairman, HCMC Medical Equipment Association (HMEA)
Positions in charge:
- Vice Chairman of HCMC Medical Equipment Association (HMEA)
- Head of Digital Transformation Department of HCMC Medical Equipment Association (HMEA)
- Vice Director of Medical Equipment Technical Consultation and Research Center
- Vice Chairman of Vietnam Waste Recycling Association
- Head of Advisory Board HCMC District 8 Business Association
- Chairman of Nguyen Tat Thanh University Business Club
- Guest lecturer of Ho Chi Minh City University of Technology (HCMUT)
- Chairman of Tan Viet My Trading Service Company Limited
Experience:
Mr. Hua Phu Doan, with nearly 40 years of experience, has been actively involved in training and organizational work in the fields of healthcare and environment. Over the past 40 years, he has participated in numerous activities organized by associations, chambers of commerce, and professional associations. He regularly organizes training programs, provides consultancy services, promotes trade, facilitates exhibitions and fairs, and conducts scientific workshops for both domestic and international entities.
Dr. Kev Lim
CEO & Founder, Qmed Asia
Dr. Kev Lim serves as the CEO and Co-Founder of Qmed Asia, where he brings a unique blend of medical expertise and technological insight to the forefront of digital health innovation. With a robust medical background garnered over seven years at leading hospitals and a pivotal role as a Clinical AI Researcher at Babylon AI, Dr. Kev's transition into digital health has been marked by significant achievements. Under his visionary leadership, Qmed Asia has revolutionized healthcare delivery by implementing advanced digital solutions across more than 4,500 providers, positively affecting over 4 million patients' lives. Dr. Kev's commitment to integrating Artificial Intelligence into healthcare is not only elevating patient care standards but also establishing new benchmarks for the industry in the region. Through his efforts, Dr. Kev continues to drive the future of healthcare, demonstrating a steadfast dedication to enhancing patient outcomes and transforming healthcare practices with innovative technology.
Mr. Preecha Bhandtivej
President, Thai Medical Device Technology Industry Association (THAIMED)
Experience:
- 38 Years experiences in Medical field
- President of Thai Medical Device Technology Industry Association ( THAIMED ) Year 2010-2024
- Chairman of ASEAN Federation of Medical Device Industry /ASEANMed Year 2012-2024
- Board committee of National Health Security Office Year 2022-2024
- 5 Board committee of Thailand Center of Excellence for Life Sciences Year 2021-2025
- Vice President of Pharmacy Council of Thailand 2022-2024
- Committee of the Medical Products Consortium of Thailand (MPCT ) Year 2019 -present
- Committee of Health Intervention and Technology Assessment Program, Ministry of Public Health - present
- Country Manager of LivaNova - Thailand -Myanmar -Cambodia -Mongolia Year 2019 – Present
- Specialist attached to Thai Senate Outstanding Committee on Commerce and Industry Year 2019-2021
Awards :
- The Outstanding Marketing Pharmacist of The Year 2011 Award, The Marketing Pharmacy Association of Thailand
- The Outstanding Marketing Pharmacist of The Year 2015 Award, The Pharmaceutical Association of Thailand Under Royal Patronage
- Outstanding person making a contribution of Thammasat University of the Year 2020
- The member (Fifth Class ) of the Most Noble Order of the Crown of Thailand