Feng-Yu Lee

Feng-Yu Lee, a consultant to the company serving in the capacity as Chief Compliance Officer, has 28 years of experience in in-vitro diagnostics and medical device industry.

Previously, Mrs. Lee was Founding Principal Consultant of the IVDD Regulatory Consulting Group where she assisted domestic and international clients with U.S. FDA device 510(k) clearances/BLAs, and Health Canada Medical Device License Applications along with US Quality System Regulations (QSR) and ISO (ISO 9001, 13485) compliance.

Prior to founding the IVDD Regulatory Consulting Company in 2009, she served foreign and domestic medical device companies in various executive and general management posts relating to device clearance, quality systems compliance and assurance. At Applied DNA Technologies and Shanghai Meikang Biological Inc., Mrs. Lee spearheaded worldwide regulatory compliance for the U.S. Division. In addition, she achieved numerous FDA device clearances and managed the regulatory, QA/QC department and drugs of abuse division of the company’s manufacturing facility in China.

In her career, Mrs. Lee has led completion of numerous clinical studies supporting both FDA and Health Canada device applications. In addition, Mrs. Lee has chaired multiple facility inspections by the FDA including a successful first time FDA inspection of a Singaporean facility in connection with an approved biological license.

Mrs. Lee graduated from Chin-Yi Institute of Technology in Taiwan. She is also a member of Regulatory Affairs Professional Society (RAPS).