Overview
As part of the International HealthTec Week, co11ab and HealthTEC.SG are bringing you expertise to share about different types of performance testing for medical devices and global regulatory strategy for startups. This event will be joined by overseas and local healthtec and medtech startups.
Programme Itinerary
Performance Testing for Medical Devices
Mr Wing Gang Seet (Director, APAC Regulatory Affairs, Cook Medical)
Quality Management Systems & Regulatory Strategy
Ms May Ng (CEO, ARQon Singapore) - Global Regulatory Strategy for Startups
Medical Device Regulation from a Startup’s Perspective
Dr Rex Tan (CTO, AEVice Health) - Where is medical device regulation in technology development life cycle: Learnings as a start-up founder
Panel Discussion
Dr Rex Tan, Ms May Ng, Mr Wing Gang Seet and Mr Ee Bin
Networking Reception
Schedule
Date: 24 Jul 2024, Wednesday
Time: 2:00 PM - 5:00 PM (GMT +8:00) Kuala Lumpur, Singapore
Location: co11ab Novena, Lee Kong Chian School of Medicine, Clinical Sciences Building 11 Mandalay Road #16-01 Singapore 308232, 308232
Speakers
Moderator's Profile:
Dr Rex Tan, Chief Technical Officer (CTO), Aevice Health
Rex is co-founder and CTO of Aevice Health, a spin off of Nanyang Technological University (NTU) in 2018. Aevice Health has received US FDA clearance and Singapore HSA approval, both in 2023, for their flagship technology, the AeviceMD, a remote patient monitor for respiratory health. Rex was a researcher, graduating with a PhD in Optics from University of Southampton in 2018 and a PhD in Engineering from NTU in 2020. He started Aevice Health with his co-founders while hiding in a basement laboratory in NTU.
Speaker's Profile:
Ms. May Ng, CEO & Global Regulatory Consultant, ARQon Group
Founder of ARQon Group, MedTech80SS, IMDS, ATTOPOLIS 828 (10 years) • Product Manager for IVDs, Poison & Radiation device (2 years) • Singapore Health Science Authority (HSA) regulation implementation and MEDICS lead, approved 1400 devices and dealers, key author guidances CSDT & GDPMDS (10 years) • Biosensors, Regulatory Director drug eluting stent in Manufacturing Site for Global approval, Technical File and audit (4 years) • Advisor for SG (NHIC, ASTAR, IPI), Korea (KHIDI), Ministry of Law's COVID Assessor, US-ASEAN Regulatory Group, International Speaker (Medica Asia, Medica Dusseldorf, Medtech Summit Europe) • Past: ASEANMed Co-chair, Singapore Manufacturing Federation Council, Medtech Industry Capability Development and Youth chair, US- China ASEAN Medical Cooperation Committee, AHWP, ASEAIN MDPWG, Trainer for Regulators, Prime Minister Office's Tech Assessor
Speaker's Profile:
Mr Ee Bin Liew, Group Executive Director, Access-2-Healthcare
Ee Bin Liew is the Group Executive Director of Access-2-Healthcare, a global consulting company with a team of 36 across 14 countries. The company helps medical technology companies around the world execute market entry activities such as go-to-market strategies, engineering design and development support, quality systems establishment, regulatory strategy and execution, business due diligence, and market access. Ee Bin has 25 years’ experience in the medical device industry, including with large multi-national companies. He remains in the forefront of the key Standards and Regulations development in the medical device industry, working directly in the ISO TC210 as part of the drafting committee for several mandatory standards in the medical device industry, and one of the Technical Committee co-chairs in the Global Harmonization Working Party (GHWP) to drive regulatory convergence.
Speaker's Profile:
Mr Wing Gang Seet, Director, APAC Regulatory Affairs, Cook Medical
With over 25 years of experience in the medical device industry, Wing Gang has held quality and regulatory affairs positions in manufacturing plants and regional headquarters of multinational corporations. Currently serving as the Director of Regulatory Affairs (RA), Asia Pacific for Cook Medical, he leads Cook Medical’s country RA teams in pre-market registration and post-market regulatory compliance efforts. Beside working in industry, Wing Gang had also worked in Regulatory Authority, having served as Deputy Director of the Medical Device Branch at the Singapore Health Sciences Authority. Wing Gang is recognized for his expertise and has been invited to share his knowledge and experiences at various regional conferences, including the Asia Harmonization Working Party (AHWP) and ASEAN Medical Device Committee (AMDC) Meeting.
