Founders

Ronda A. Balham, OD

Ronda A. Balham, O.D., has 20 years of FDA experience in many capacities including several years at the Center for Devices and Radiological Health (CDRH) where she began her career as a clinical reviewer. Dr. Balham brings to Kinexum her expertise in the premarket approval and clearance processes for medical devices; the Humanitarian Device Exemption process; and regulatory due diligence for medical device products.

Ronda also has extensive experience in the international regulation of medical devices having spent time as a Mansfield Fellow working at the Ministry of Health, Labour and Welfare in Japan in both the medical device and orphan product divisions, several years as the Executive Secretariat for the Global Harmonization Task Force, and several years as a medical device consultant in Europe.

Dr. Balham specializes in profiling medical device and diagnostic products, national and international regulatory strategies, designing regulatory communication with FDA and other national regulatory authorities including responding to emergencies such as product recalls.