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Publications and quotation :
Regulatory and Quality Compliance:
Our CEO, Jim-Son Chou, Ph.D., have worked in several pharmaceutical and medical device companies. He has successfully obtained PMMA approval and launch new products. The reprint below was published in Pharmacia's Journal Dated September 1997 .(Click here for PDF) This was a approval of intraocular implant(class III device) through a fast track submission.
Besides the PMA's, he has assisted manufacturers to obtain 510(K) approvals in the field of glaucoma drainage systems, safety syringes, powered muscle stimulation system , transcutaneous electrical nerve stimulators(TENS) and In vitro Diagnostics systems, etc.
He has been participating in Quality System panels and medical device standard panels. The reprint attached was from The Silver Sheet regarding to his address in the Quality System Implementation Panel discussion .(Click here for PDF)
Medical Device R&D Engineering :
"Excimer Laser Surgery of the Cornea". C.A. Puliafito, M.D., R.F. Steinert, M.D., E.J. Dehm, J.S. Chou, Intraocular Lens Implantation Congress, April 11, 1985.
"Percutaneous Transluminal Microwave Balloon". J.S. Chou et.al IEEE Transaction on Microwave Theory and Techniques, 38,90 (1990).
"Evaluation of the Koziol-Peyman Teledioptric System for Age-Related Macular Degeneration". J. Hersh, J. Koziol, J.S. Chou, Optometry and Vision Science, 68, 173, (1991).
"Intraocular Telephoto System Design Using First-Order Parameters". J.S. Chou, A.. C. Ting, Optometry and Vision Science, December, 28, (1992)
"Diffractive-Refractive Lens System for Age-Related Macular Degeneration". A. C. Ting, D. G. Koch, J. S. Chou, SPIE Biomedical Optics Technologies, Vol. 1877 p185-189, 1993
“Teledioptric system for Age Related Macular Degeneration”, J.S. Chou, A.C. Ting, SPIE Ophthalmic Technologies, Vol. 2127, p128-135, 1994
“Evaluation and Implantation of a Teledioptric Lens System for Cataract and Age-Related Macular Degeneration”, J.E. Koziol, G.A. Peyman, J. S. Chou et. al, Ophthalmic Surgery, 25, 675, 1994
“MTF Measurement System that Simulates IOL performance in the Human Eye”, J.S. Chou, L. Blake, J.M. Fridge, D.A. Fridge, SPIE Ophthalmic Technologies, Vol. 2393, p271-279, 1995
“Comparison of Baerveldt Glaucoma Implant with bioseal to Baerveldt implant in rabbits”, Baerveldt G., Chou J.S., Longren B. Invest Ophtalmol Vis Sci, 38, 52, 1997
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