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