• Leading FDA Expert
• Brought more than 40 Class II and Class III
devices from R&D through clinical trials,
manufacturing, to FDA-approval.
• Developing quality systems and preparing
regulatory submission.
• Wrote 50 successful submissions to CDRH
and CBER of the FDA.
• BS in microbiology: University of South Florida,
• PhD in virology/molecular biology at Virginia
Tech, Postdoctoral Fellow in Biochemistry
Harvard