Scope
The Technical Committee for Medical Devices and Quality Management Systems (TC-MDQM) develops, reviews and promotes standards and any related standardisation activities through identification of standardisation needs and gaps in the areas of:
- Medical device design and development;
- Quality management systems in field of biomedical and health.
Working Groups
The Technical Committee for Medical Devices and Quality Management Systems oversees the following working groups in the development of standards and participation in international standardisation activities within the respective domains.
Biological and clinical evaluation of medical devices
NMWG for ISO/TC 194
Quality management in medical devices
NMWG for ISO/TC 210
Good distribution practice for medical devices
WG-620
Thermal imager
WG-582
Medical Device Clinical Investigation
WG-MD
Technical Committee Composition
Ms Heidi GOH
Chair
Ms GOH was formally the Vice President of Quality at Edwards LifeSciences (Singapore) and Quality Director at Baxter Healthcare, with extensive expertise in Quality Management Systems. She is currently serving on this Technical Committee for a third term.
Ms CHAN Yang Sun
Deputy Chair
Ms CHAN is currently is currently the Quality Assurance and Regulatory Affairs Lead at Diagnostics Development Hub (DxD Hub) of A*STAR. She brings extensive quality control experience from her previous roles at Macrogen, Abbott, and the Genome Institute of Singapore.
Members in alphabetic order of surnames:
| Ms Jasmine Chan Shiyu | Individual Capacity |
| Ms Chua Chui Khim | Becton Dickinson Medical Products Pte Ltd |
| Assoc Prof Leo Hwa Liang | National University of Singapore (NUS) |
| Prof Lin Zhe / Mr Randy Teo | Singapore MedTech Consortium |
| Prof Raye Yeow | Biomedical Engineering Society (Singapore) |
| Ms Iris Tan | SingHealth |
| Ms Tan Yuhua | Health Sciences Authority (HSA) |
| Mr Andy Wong | Singapore Accreditation Council (SAC) |
| Dr Wong Yee Shan | Temasek Polytechnic (TP) |
| Ms Zhu Huifang | Individual Capacity |
Standards
The Technical Committee for Medical Devices and Quality Management Systems oversees these national standards, published through the adoption of international standards or the development of standards in collaboration with industry experts.
