May Ng is the Global Director of ARQon, Asia Regulatory & Quality Consultancy for medical devices and drugs, assisting in product development and registration in Asia, CE and global approval. She is also an advisor for National Health Innovation Centre (NHIC) on all government hospital clinical trial funding in Singapore and sits on the main committee of Singapore Manufacturing Federation's Medtech Industry Group, ASEANMed and China-ASEAN Medical.
May was in Singapore Health Sciences Authority (HSA) for almost 10 years to complete the implementation of the Singapore regulatory framework based on IMDRF/GHTF principles, and reviewing/approval of companies with ISO13485/GDPMDS and medical device/IVD. She joined Biosensors drug-coated stent manufacturing headquarter in Singapore for four years as Regulatory Director after two years working in the IVD industry.
May has degrees in Biochemistry & Microbiology, Biomedical Engineering, and Medtech Manufacturing.
- Product Development Technical Documentation
- Quality Management System (ISO13485, USQSR, MDSAP, GDPMD)
- Clinical Trial & Clinical Evaluation
- Manufacturing Plant Set-up & Process Validation
- Global Product Registration & Product license holding
- Distributor Search & Distribution
- Regulatory Management (Strategy & Market Access)
- Training to Manufacturer, Trading, Association, Regulator
- Manufacturing - Product Design & Development, Test & Verification/Clinical Trials, Certification/Regulatory Compliance
- Healthcare - Product Design & Development, Test & Verification/Clinical Trials, Certification/Regulatory Compliance
- Life Sciences - Product Design & Development, Test & Verification/Clinical Trials, Certification/Regulatory Compliance