Dulciana Chan received her B.S. in Biomedical Engineering from Johns Hopkins University, and her M.S.E. in Bioengineering from the University of Maryland. Dulciana worked in FDA in the Center for Devices and Radiological Health (CDRH) in both the  Office of Science and Engineering Laboratories (OSEL) and Office of Product Evaluation and Quality (OPEQ) for 14 years in several roles including research associate, scientific reviewer and policy analyst. Dulciana then transitioned to regulatory consulting, working with clients of all sizes ranging from universities and small start-ups to established medical devices companies across multiple product areas. Her experience as a Principal Consultant includes providing regulatory strategies, preparing and submitting medical device submissions (510(k), pre-submissions, IDE, PMA, Breakthrough Designation), and acting as liaison for FDA interactions. Areas of expertise include electromagnetic compatibility (EMC) testing and electrical safety.

Product Experience

Patient Physiological Monitors

Software as a Medical Device (SaMD)

Radiology Software

Thermal Regulating Systems

Continuous Measurement Thermometers

Injection Data Capture Devices

Ophthalmic Lasers

Light based over the counter devices