Mr. Jeffrey Chern
Founder
- Former US FDA 510(k) AP reviewer, Taiwan FDA reviewer, Taiwan GMP lead auditor, EU Notified Body auditor, CLSI member
- Speaker, ITRI College
- Advisor, NTU SPARK Program
- Former GHTF SG1 & AHWP expert
- Author of Taiwan FDA, GHTF, AHWP guidances
- Experienced in GMP/ISO13485 consultation & registration consultation in US, EU, China, Taiwan, and other countries
Dr. Luke Pan
Co-Founder
- Physician-in-charge, former Center for Drug Evaluation reviewer, assisting TFDA to review clinical data
- Speaker, ITRI College
- Familiar with clinical trial regulation, ISO 14155 and GCP
- Experienced in clinical trial data review and consultation
Mr. Kris Shen
Co-Founder
- MSc in Biotechnology, former RA manager of domestic manufacturer, product specialist of domestic distributor, RD engineer of domestic manufacturer
- Former Center for Drug Evaluation reviewer & TFDA reviewer, assisting TFDA in conducting high-risk medical devices
- Speaker, ITRI College
- Familiar with medical device R & D Processes, TPLC regulations, and preclinical evaluations
