Work Group 6 (WG6) - Quality Management System: Audit & Assessment

Submitted by admin on Fri, 06/02/2017 - 16:52
Chair: Mr. Abdullah AL RASHEED
Compliance and Enforcement Excutive Director
Saudi Food & Drug Authority
Kingdom of Saudi Arabia
Regulatory Authority

Co-Chair:
Mr. Vincent Chee-Choong LAM
Senior Product Specialist
TUV SUD Product Service
TUV SUD
Malaysia
Industry
Member: Ms. LEE Szu-Yu
Specialist/GMP Inspector
Taiwan Food & Drug Administration
Chinese Taipei
Regulatory Authority
Member: Dr. Adel Ahmad ALHAJJI
Medical supply administration
Ministry of health
State of Kuwait
Regulatory Authority
Member: Ir. Sasikala Devi THANGAVELU
Director
Medical Device Authority
Malaysia
Regulatory Authority
Member: Mr Kyoung Taek LIM
Assistant Director
MFDS
Republic of Korea
Regulatory Authority
Member: Mr. Asok KUMAR
J & J Medical India
India
Industry
Member: Dr. Vincent Chee Choong LAM
Certification and Inspection Manager
TUV-SUD-PSB (Malaysia) Sdn. Bhd.
Malaysia
Industry
Member: Ms. Fong An LEE
Deputy Manager
Office of Medical Device Evaluation
Center for Measurement Standards/ Industrial Technology Research Institute
Chinese Taipei
Industry
Member: Ms. Xiaohua, Jessie LI
Johnson & Johnson Medical (Suzhou) Ltd.
People's Republic of China
Industry
Member: Mr. Tony LOW
Manager
BS-P Medical South East Asia
TUV Rheinland
Malaysia
Industry
Member: Mr. Vidya SHANKAR
Sr Manager - Quality
Philips Electronics India Ltd, Healthcare Sector
India
Industry
Member: Ms. TAN Hwee Ee
DH RegSys Pte. Ltd.
Singapore
Industry
Member: Mr. FAN Hong Teng, Kelvin
QM Manager
Sysmex Asia Pacific Pte Ltd
Singapore
Industry
Member: Ms. NARAYAN Murthy Indira B
Head - Regulatory, Quality & Compliance,
India & South Asia
Abbott India
Industry
Member:

Ms. SUMATI  Randeo
Associate Director
Regulatory Strategy & Advocacy
Strategic RA Asia Pacific
Abbott Quality and Regulatory
Abbott Laboratories
India

Industry
Member: Mr. Albert LI T.W.
Manager
Industrial Technology Research Institute
Chinese Taipei
Industry
Member: Ms. Jennifer HAN 
Supervisor/RA/Qsuality system
3M China Limited
China
Industry
Member: Ms. Nishith DESAI
Director of Regulatory Affairs, New Products, Asia
COVIDIEN PRIVATE LTD
Singapore 
Industry
Member: Ms. Hailey CHU
Medical Device Product Manager
British Standards Institution
Chinese Taipei
Industry
Member: Ms. Melody Kwok
Regulatory & Quality Consultant
ARQon Pte Ltd
Singapore
Industry
Member: Mr. L.Praveen Kumar
Director
Quality, Regulatory Affiars & EHS
India Medtronic Pvt. Ltd. 
Industry
Member:

Ms Rachel Chung
Managing Director, Medical Devie Group 1
Synex Consulting Ltd.
Republic of Korea

Industry
Member:

Ms Ji Yeun KIM
Director
RAQA / Reimbursement
Stryker Korea
Republic of Korea

Industry
Member: Ms Latika Vats
Director
Regulatory Affairs & Quality Assurance
Terumo India Private Limited
India
Industry


Guidance Documents: 

FINAL_imdrf-tech-140918-assessment-decision-process-141013

FINAL_imdrf-tech-131209-competence-and-training-requirements-140901 

FINAL_imdrf-tech-131209-auditing-requirements-140901

FINAL_imdrf-proc-140918-decision-related-processes

AHWP-WG4-Nov2012-FINAL (part1)

AHWP-WG4-Nov2012-FINAL (part2)

AHWP-WG4-Nov2012-FINAL (part3)

AHWP-WG4-Nov2012-FINAL (part4)

AHWP-WG4-Nov2012-FINAL (part5)


Work Plan and Target: 

AHWP_TC_WG04_Work Plan 2012-2014

AHWP_TC_WG06_Work Plan 2012-2014