Outstanding Alumnus: CHU, FEN-YU

Current Position:

1. DYNAMIC BIOTECH INC. (U.S.)
2. President, Elite BioMedical Consulting Inc & Head Legal Counsel (Taiwan)

Notable Achievements:

Special Cases or International Achievements in Recent Years:

1. In 2017, Four iPhone models received FDA 510(k) clearance in vitro diagnostic testing.
2. In 2018, passed nine FDA 510(k) reviews; MDSAP Guidance and audit pass.
3. 2019 until now, Elite BioMedical has received ISO9001 Certification.
4. In 2019, SaMD and B.E.S.T INNOVATION Certification Guidance.
5. In 2020, obtain FDA EUA high-level medical SaMD only in 21 Days; Obtain the world’s highest Optical Coherence Tomography FDA 510(k) Principal Investigator review only in 84 days; Complete responses to FDA Pre-Submission of Medical AI Optical Imaging Software for Stained Colorectal Tissue Slides.
6. Individual or organization with the most FDA 510(k) clearances for blood glucose testing devices globally in the past 15 years.