Taiwan Medical Devices Webinar

Dr. James Leu has more than 25 years of EHS consulting experience. He has directed and managed numerous Phase I and II environmental site assessment, environmental health and safety (EHS) management system and corporate audit programs, EHS due diligence, environmental & social due diligence, product stewardship & chemical registration, site investigation and remediation, waste management, environmental permitting, EHS monitoring and regulatory compliance assessments for both local and multi-national corporations.
He has directed, managed and conducted over 1,000 EHS and product stewardship related consulting projects in Taiwan, China, Thailand, Vietnam and the Philippines.

Rolen Liu is a consultant who has over 8 years in the medical device, clinical trial, and pharma field with a pharmacy background and is based in ERM Taiwan.
His expertise lies in medical device registration, coordinating device constituents of combination products, reviewing, and assembling for customer regulatory submissions (NDAs, INDs), reviewing post-approval supplements, including evaluation of documents for accuracy and conformance with reference to applicable regulations, as well as planning and executing registration strategies to meet initiatives and timeline.