Committed to creating bridges between
Medical Device Manufacturers and Markets

Dr. Zafirios Gourgouliatos, Ph.D., Regulatory Specialist and Company Founder,is a biomedical and optical engineer with over 20 years of experience in the medical device industry. After earning his undergraduate degree in electrical engineering, Dr. Gourgouliatos 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. Dr. Gourgouliatos holds six patents.

2000 - 2013 Company Co-founder and Chief Technology Officer, Lerner Medical Devices, Inc., Los Angeles, CA. Fundraising and company organization; successful grant applications, new product development (definition, specification, design, manufacturing set-up, 510(k) regulatory approval, product launching, organization of clinical trials, ISO registration). Exploration on novel applications of fiber optic lighting for medical and industrial applications. Intellectual property portfolio development. Principal investigator in the SBIR award that funded initial development of the Levia® LiteBrush™ during Lerner Medical's start-up phase.

1997-1999 Photomedicine Specialist - Senior Scientist, Bunsen Rush Laboratories, Inc., Los Angeles, CA. Feasibility studies, proposal writing, and business organization. The Small Business Innovative Research proposal submitted to the National Institutes of Health, for a "Novel Fiber Optic Light Source for Treatment of Scalp Psoriasis." was funded (SBIR-Phase I & II, $850,000) and provided the seed money for Lerner Medical.

1992-1997 Photomedicine Specialist - Project Leader, Cogent Light Technologies, Santa Clarita CA. Development of novel single fiber high power systems for medical and industrial applications implementing a patented light collection scheme. Responsible for the R&D effort to turn a patent stage concept into an FDA approved product.

1987-1991 Biomedical Optics Consultant, at the Laser Institute of the Medical School of the University of Utah. Argon, Argon Dye, Metal Vapor, Nd:YAG and Free Electron Laser applications in medicine & biology, experiments with new photodynamic therapy drugs.

1985-1986 Maintenance and Repair Specialist for Electronic Boards, Dell Computers, Austin, TX. Worked with Michael Dell at Dell Computers during its very early stages, while the company had just a dozen employees.

1985-1990 Research Assistant, University of Texas at Austin, Biomedical Eng. Dept...
Analysis of laser - tissue interaction, laser treatment of skin lesions, photodynamic therapy, optical instrumentation. Research on laser applications in medicine

.1982-1984 Electrical Engineer, for Private Business and Industry in Greece. Sound and Light System development and installation for entertainment spaces.

 Zafirios Gourgouliatos Resume in PDF

Experience

• FDA Compliance
• Regulatory
  Registrations
• Risk Management
• 510(k) Submission
  (Pre-Market Notification)
• Quality System Compliance
• Crisis Management
• Safety Testing
• Technical File
• IDE
• PMA
• Human Factors
• ISO Registration, CE Marking
• DMEPOS Accreditation
• DME/HCPCS 
• HIPAA 

  Education

Ph.D. in Biomedical Engineering, The University of Texas at Austin, 1990

M.S. in Biomedical Engineering, The University of Texas at Austin, 1986

B.S. in Electrical Engineering, The University of Patras,1983