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ARQon's Services
ARQon国际商务集团专注于监管咨询、商业咨询及服务、培训及数字平台，旨在支持企业获得全球市场准入。
我们的团队结合了行业经验和前监管机构背景、地方网络和关系，以帮助您实现监管和市场目标，制定稳固的市场准入策略，因为我们了解您的产品类型的监管快速通道和要求。我们在全球范围内提供服务，以满足您的不同需求。
Regulatory Approval
Business Ventures
B2B2C Global Ecosystems
Training & Incubator
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产品注册（医疗器械、药品、化妆品、保健品、包装与安全）
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国内持证
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Tapping Manufacturer ISO & Distributor GDP
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QMS ISO13485/GDP/QSR/CE set up/Supplier Audit
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Regulatory Strategy, Technical File, Clinical and CER
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QuikQuality RAQA Dashboard
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Monthly support RA/QA/Admin
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Business setup
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Matching (Distributor, CDMO, Investor, Clinician, Partner)
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Overseas business development (Outlet, Online Shop, Booth)
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Market strategy & branding
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Omnichannel Social Media Marketing management
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Experts Legal, IP, Investment, Compliance, Corporate services
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Product & Service Marketplace
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One Stop Business Solution
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Showcase Innovations & Consumer Care
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Country Pavilion with Embassy/Association
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Networking, Event, Forum
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Outreach Partner Program
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Training for MedTech Professionals (design, manufacturing to commercialization)
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Incubator for Entrepreneurs
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Alliance for Healthcare Startup in Asia
ARQon Management Team
May Ng
Group CEO
• Founder of ARQon Group, IMDS, ATTOPOLIS B2B (10 years)
• Product Manager for IVDs, Poison & Radiation device (2 years)
• Singapore Health Science Authority (HSA) regulation implementation & MEDICS lead, approved 1400 devices & dealers, key author guidances CSDT & GDPMDS (10 years)
• Biosensors, Regulatory Director drug eluting stent in Manufacturing Site for Global approval, Technical Fille & 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 Düsseldorf, Medtech Summit Europe)
• Past: ASEANMed Co-chair, Singapore Manufacturing Federation Council, Medtech Industry Capability Development & Youth chair, US-China ASEAN Medical Cooperation Committee, AHWP, ASEAN MDPWG, Trainer for Regulators, Prime Minister Office’s Tech Assessor
OUR TEAM
Stephen Hsu
Quality & Tech Director
QUALITY & TECH
Ray Soh
Global Regulatory Director
REGULATORY, Device
Dr Wong Tee Wee
Global Regulatory Director
REGULATORY, Drugs
Al Low
International Venture Services Director
COMMERCIAL, Global
Deepak Jamle
Business Marketing
Deputy Director
RUSHESGROUP
Beatrice
Project Coordinator
REGULATORY & QUALITY
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Ray Lee
Public Relation Officer
Customer Service
Afif
Regulatory & Quality Manager
REGULATORY & QUALITY
Tyler Chong
Business & Supply Chain Manager
Supply Chain
Salome
Business Manager
Clinical & Attopolis
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Our Clients
Regulatory
• Product registration & Product License Holder for implant, IVD, AI & therapeutics, (eg drug, supplement)
• Monthly regulatory support for regional registration
• Wireless, radiation & mandatory packaging reporting to Authority
• Post-market reporting to Authority on adverse event & recall
B2B Marketplace,
Forum, News
• Product listing by manufacturer
• Post forum used by startups to request for distributor search
• Service providers (eg contract manufacturer & translation) to list their service
• Distributors to look for innovation product
• Organizations to post event, HSA focus group & public consultation, funding to share to medtech professionals.
Commercial
• Connect to Clinician, advise on new indications & training. Connect 3PL or Tapping MedtechBOSS Importer/Wholesaler/Product owner GDPMD/ISO for supply to hospitals
• Country Trade mission business matching for EU companies to SG potential partners (1-5 per company)
• Find & Set up Importer, Distributor, Rep License with MOH, advise staff hiring & space compliance requirements (eg Indonesia)
• Provide clinical funding, regulatory & commercial support (eg tech licensee, investor to the start-up for working with all 6 clusters of SG hospitals Innovation centre)
Quality
• ISO 13485, MDSAP, USQSR, MDR, IVDR QMS setup, supplier, internal/mock audit, maintain when staff leaves/left
• MDD, IVDD transition to MDR, IVR with gap analysis, compliance work
• GMP Biologics advisory for HSA certification audit, Process validation advisory
• Global Regulatory Strategy, Classification and Borderline Drug/Device/Lifestyle/Cosmetic assessment
Technical
• Provide template, guide & check technical documents to build Design History File, Medical Device File
• Training to industry & regulator on ISO 13485, Design Control, Asia Registration, MDSAP, Global regulatory strategy, ASEAN CSDT & review requirements for approval
• Biocompatibility assessment requirements, Clinical Evaluation Plan & Report
