Work Group 8 (WG8) - Standards

Chair: Mrs. Salbiah Yaakop
Senior Principal Assistant Director
Medical Device Authority
Ministry of Health
Malaysia
 Regulatory Authority
Co-Chair: Mr. Tony LOW
Director of QA/RA and Human Performance
Commissioning Agents International
Malaysia
 Industry
Secretary:  Mr. Ik Soo KIM
Chief 
Medical Devices Testing & Certification Center
DT&C Co., Ltd
Republic of Korea
Industry
Advisor: Dr. Gert W. BOS  
Member: Mr. Sung Wook CHOO
Assistant Director
MFDS
Republic of Korea
Regulatory Authority
Member: Mr. Rajaram BALASUBRAMANIAN
Director - QA & RA
Elekta Medical Systems (India) Limited
Tamilnadu, India
Industry
Member: Ms. Ade Herawati PURNAMASARI
Regulatory Affairs Leader – Indonesia
PT GE OPERATIONS
Indonesia
Industry
Member: Ms. Lesley TAN
Technical Consultant
UL International (S) Pte Ltd
Singapore
Industry
Member: Ms. Latika Vats
Director
Regulatory Affairs & Quality Assurance
Terumo India Private Limited
India
Industry
Member: Mr. Kim Euncheol
Researcher
Medical Device Information & Technology Assistance Center
Republic of Korea
Industry
Member: Mr. Fang Zhou FENG
International RA Supervisor
Shanghai Kinetic Medical Co., Ltd
People's Republic of China
Industry
Member: Dr. Young Huh
Program Director
Korea Evaluation Institute of Industrial Technology
Republic of Korea
Industry
Member:

Dr. Christopher Chan
Senior Engineer
Industrial Technology Research Institute
Taiwan

Industry