Vicente Hsu

Regulatory Affairs Manager

Regulatory Affairs lead with over ten years of experience in medical device regulations and registration, covering notified body conformity assessments, technical documentation review, regulatory affairs management for manufacturers, and multi-regional product registrations (EU MDR/IVDR, U.S. FDA, and Taiwan TFDA). Formerly served as a Lead Technical Reviewer and Auditor at SGS Global Medical Device Office, and recently led MDR/IVDR compliance projects for multinational corporations.