ABOUT

I have been working in the medical device and regenerative medicine field since completing my postdoctoral research at Emory University in Tissue Engineering in 2007. In my career, I have managed multiple projects for Class II and Class III devices and tissue based biotherapeutics following CFR Title 21 and ISO 13485 guidelines for medical device design, development and production and ISO 14971 for the application of risk management for medical devices. I am PMP certified by PMI, and I am an expert in requirements for BLA, PMA, IND, IDE, 510K, HUD, and HDE submissions and CFR Title 21 for medical device design, manufacturing and reporting.

In addition, I have managed the Implementation of potency, purity, and identity assays for CMC requirements for BLA indications, the execution of pharmacokinetics, pharmacodynamics, and safety studies to support preclinical evaluation as well as development of bench, cell-based, and preclinical studies to identify molecular mechanisms for efficacy of amnion derived biotherapeutics. 

I am an expert in the design and development of cardiovascular devices and heart valves, and led the design and development of heart valves from feasibility to IDE approval.