Quality Management System

HUKUI excels in advanced manufacturing and supply chain expertise in Quality Management System(ISO13485),regulation & certification, QA/QC inspection process and supply chain management, making us the prime choice for seamless Concept-to-Customer solutions.


Global regulatory affairs registration services including CE, FDA, Taiwan FDA and China NMPA etc.
Hukui can guide the medical device innovators through the intricate processes and get the products onto the market on the correct track.

Taiwan Registration
US Registration
EU Registration
China Registration
QC Flow Chart
Supply Chain Management