Hwee Ee Tan's Biography

Hwee Ee Tan, Principal Consultant/Director, DH RegSys Pte Ltd

HweeEe has more than 25 years of experience in the medical device industry and worked in manufacturing as Engineer and also in Senior Management roles in QA / RA. She also worked as a Consultant in a Pharma/Device consultancy company. In 2010, HweeEe founded DH RegSys Pte Ltd to provide advisory services to the medical device industry with focus on Regulatory Affairs and Quality Management Systems. During the past few years, the consultancy services have expanded to include providing regulatory support for medical device clinical trials in China and the region. HweeEe provides training on both Regulatory and QMS (eg ISO13485 and compliance to 21CFR Part 820). She is a member of Asian Harmonization Work Party (AHWP); Working Group 6 (WG6) Quality Management Systems: Audit & Assessment.