Judy F. Gordon, D.V.M.

Founder and president of ClinReg Consulting Services, Inc., Dr. Gordon has over 20 years progressive clinical, regulatory, quality and R&D experience in the pharmaceutical and medical device industries. Her accomplishments include:
•   Gaining FDA approval for multiple (10 original, 4 clinical modules) PMAs for Class III devices, including presentations to Advisory Committees.
•   Directing clinical trials of biologics, pharmaceuticals, and Class I, II and III medical devices, from protocol development through clinical reporting to FDA.
•   Successful management of QSR and notified body inspections, leading to FDA approval of manufacturing facilities and CE marking.

Dr. Gordon has served as the industry representative to both the Medical Devices Dispute Resolution Advisory Panel and the Ophthalmic Devices Advisory Panel of the FDA.

Yi Jing Duh, Ph.D.

Dr. Duh has 15 years of experience as a senior statistician and manager of statistical services, including responsibility for clinical database development and validation, as well as SAS programming and output in support of PMA and NDA applications. Her accomplishments include:
•  Data analysis and reporting in support of multiple PMAs/NDAs since 1991.
•  Negotiation of statistical analysis plans, including imputation strategies with FDA statisticians during PMA and NDA planning and review.
•  Clinical database planning, development and validation, with successful audits by FDA bioresearch monitoring investigators.
•  Statistical planning for clinical trials, DSMB and SAB meetings, and interim reporting to FDA.

Eeke Romo, D.Sc.

A Dutch-trained physician, Dr. Romo gained broad expertise in the design and conduct of experimental research studies while on staff at the University of California, Irvine. For 10 years, she managed clinical trials for product development at Baxter Healthcare (Edwards Division) and Theracardia, a venture-backed private company. Currently, Dr. Romo prepares clinical study protocols and reports for FDA submissions, develops table formats for data reporting, reviews and prepares adverse event summaries, and has produced final clinical reports for several original PMA submissions.

Dave Fernquist

A seasoned regulatory professional with nearly 20 years of experience in managing clinical trials and regulatory submissions for medical device companies, Mr. Fernquist joined ClinReg Consulting Services, Inc. in 2003, and since then has taken full responsibility for multiple IDEs and a PMA. Over the course of his career, Mr. Fernquist has participated in the preparation of a large number of IDEs, 510(k)s, and PMAs in the fields of ophthalmology, dental implants, coronary stents and delivery systems, in vitro diagnostics, implants for urinary incontinence and prostate cancer, and transcutaneous nerve-stimulation therapy.

Steven M. Kair, M.A.

Mr. Kair has more than 25 years of experience in the medical device industry, clinical research and quality assurance. He has been directly responsible for overseeing multiple clinical investigations, each involving 150 to 800 patients, and received FDA premarket approval for more than 70 ophthalmic medical devices. In addition to regulatory submissions, Mr. Kair has extensive experience conducting clinical audits in conformance with the Good Clinical Practices requirements of the International Conference on Harmonization and ISO 14155, and is well versed in the conformity assessment requirements of the EU Medical Device Directive, compilation of technical files, design dossiers, investigator brochures and implementation and coordination of clinical trials in Europe.