Speakers

Keynote Speakers

                                                                       

    Mr. Li has been employed by Industrial Technology Research Institute (ITRI) since 1990 and established the Office of Medical Device Evaluation in 1999. The Office of Medical Device Evaluation is responsible for ITRI regulatory service programs including US FDA 510(k) Third Party Review Accredited Person, US FDA Medical Device QS/GMP Third Party Inspection Accredited Person, Taiwan medical device GMP inspection, and Class II In Vitro Diagnostic Device premarket review.

He has been the leader of numerous DOH projects to revise the medical device regulatory system of Taiwan since 1998. He audits more than 200 medical device manufacturers in Taiwan, US, Japan, Singapore and China in accordance with Taiwan, US and EU medical device regulatory requirements.

Mr. Li has been a member of GHTF SG4 since 1999. He was the Chairman of Asian Harmonization Working Party /Technical Committee in 2000~2005 and a member of AHWP TC representing Chinese Taipei and the liaison of GHTF SG4.