Dr. Gourgouliatos is a Biomedical and Optical Engineer with over 30 years of experience in the medical device industry, currently focusing on Regulatory Affairs, including:• FDA Premarket Approval (PMA) & Pre-subs (Q-Sub) meetings• Preparation of 510(k) Substantial Equivalency applications• Technical File preparation/review for CE Marking• Responding to and resolving Notified Body queries• MDD to MDR and IVDD to IVDR transition - QMS updates• FDA, Canada, International product registration support• Devices incorporating Medicinal Products• Clinical Trial protocol development, IRB, monitoring• Risk Management and Usability, initial reports and updates• Label and IFU review for FDA and EU compliance• GSPR, FMEA and Hazard Analysis preparation• Clinical Evaluation Report (CER) preparation - Literature review• Post Market Surveillance (PMS) & Clinical Follow-up (PMCF)• EUDAMED Reporting - Periodic Safety Update Reports (PSUR)• Summary of Safety and Clinical Performance (SSCP)• Zafirios, after earning his undergraduate degree in Electrical Engineering, pursued graduate studies in Biomedical Engineering as a Fulbright Scholar at the University of Texas in Austin. His doctoral research involved the interaction of light with tissue and the effects of laser light on the skin. Before starting Lerner Medical Devices, Inc., he managed development of endoscopic illumination at Cogent Light Technologies. Dr. Gourgouliatos was the principal investigator in the SBIR award that funded initial development of the Levia LiteBrush™ during Lerner Medical's start-up phase.• At the time of the exit of Lerner Medical though the sale of its technology and product lines, he was also leading a group of professional at Leilux, Inc. a consulting services company in the areas of new product and business development, regulatory strategy, reimbursement planning, and fundraising.• He holds eight patents