Zafirios Gourgouliatos, Ph.D. Email & Phone Number

Los Angeles, Ca, Us

United States

Documentation remediation for Medical Device Regulation complianceResponses to Notified Body Technical Documentation RFAIs (Requests for Additional Documentation)510(k) Application supportMedical Devices with Active Pharmaceutical Substances - Medicinal Substance DossierUsability in Medical Devices (IEC 62366-1:2015)European Union EMDN Code assignment and applications for new codesRoHS, REACH, and WEEE ComplianceFeeding pumps and enteral nuitrition

Irvine, California, United States

Management of diverse regulatory functions in the field of In Vitro Fertilization and Assisted Reproduction Technology• MDD to MDR update of QMS system• US FDA 510(k) Premarket Notifications - Class II Devices• EU MDR compliance and Technical File preparation for Class IIb and III Devices that incorporate medicinal substances• Responding to and resolving Notified Body queries• Post Market Surveillance (PMS) and Clinical Follow-up (PMCF)• Clinical Evaluation Report (CER), Literature review• Periodic Safety Update Reports (PSUR)• Summary of Safety and Clinical Performance (SSCP) for EUDAMED.• Risk Management Report update to current ISO standards• GSPR, FMEA and Hazard Analysis preparation• International product registration support

Sylmar, Ca

Responsible for diverse regulatory and engineering functions:• Class III regulatory submissions for Orion®, a brain implant creating artificial vision for blind people• System review for the brain neurostimulator connected via wireless to an external video camera• Q-sub meetings with the FDA for end point definitions in the Early Feasibility IDE study• Analysis of camera to implant wireless link performance for FCC transmitter registration• Test specifications for qualifying hermetic seal of electronics housing – Helium leak rate• Literature Review, Post Market Clinical Follow up and adverse effects reports for patient base• Responses to Notified Body queries on Technical File reviews and facility inspection findings

Los Angeles

• Regulatory strategy, FDA preparedness for device companies• Design, prototyping, V&V testing of medical devices• Preparation of 510(k) Substantial Equivalency applications• Technical File preparation under MDR/documentation review for CE Marking• Responding to and resolving Notified Body queries• MDD to MDR and IVDD to IVDR transition, gap analysis and QMS updates• FDA, Canada, International product registration support• Devices incorporating Medicinal Products• Clinical Trial protocol development, IRB, trial monitoring• Risk Management under ISO 14971:2019 and ISO TR 24971:2020• Application of Usability Process for Medical Devices per IEC 62366• Label and IFU review for FDA and EU-MDR compliance• General Safety and Performance Requirements (GSPR) preparation• Clinical Evaluation Report (CER) preparation• Literature review• Post Market Surveillance (PMS) & Clinical Follow-up (PMCF)• EUDAMED - Periodic Safety Update Reports (PSUR)• Summary of Safety and Clinical Performance (SSCP)

Greater Los Angeles Area

• Started company with SBIR grants and angel investor funds to develop a UVB fiber-optic device• Completed product development and commercialization with funds from institutional investors• Product design, IDE, IRB, clinical trials, design for volume production, FDA clearance, CE Mark• Creation of Technical Files• Preparation and submission of 510(k) applications• Company Representative during FDA and Regulatory Body inspections• Software specifications, drafting of testing protocols, reporting on performance evaluation• Organized departments and brought product to market; developed IP portfolio• Led the company to strategic exit through acquisition of UVB Psoriasis Treatment product lines

Santa Clarita, Ca

• Organized optical lab, medical device electrical safety and electromagnetic compatibility testing• Design and clinical testing of endoscopic illumination systems, design transfer to manufacturing• Design of lightweight surgical headlight, light scalpels, fiber-optic coupling connectors• Design and testing of high voltage power supplies; logic design of human interface.• Responses to examiner reviews of patent applications; filing of trademarks

Certificate, Medical Devices, Course Completion Certificate

Courses Completed: Role of the Regulatory Professional Regulatory Professional Ethics Medical Devices: Definition and Lifecycle Global.

Ph. D., Biomedical Engineering

Investigation of Light-Tissue Interaction using laser light and "​in vivo" animal models. Real time visualization of blood vessel changes.

Master’S Degree, Biomedical/Medical Engineering

Optical changes of tissue with thermal damage to simulate non linear phenomena observed during medical procures with lasers.

Bachelor’S Degree, Electrical Engineering

Focus on Analog/Digital Electronics and Wire/Wireless Communications.