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O’CONNELL REGULATORY
CONSULTANTS, INC. is a consulting practice which
specializes in medical device regulatory affairs and
clinical study management, focusing on obtaining FDA
marketing approval for medical devices and
combination drug/device products. Domestically, we
assist a variety of clients including small
companies who may be seeking their first FDA
clearance, larger firms who need assistance with a
single submission or support during a clinical
trial, or manufacturers who lack expertise in a
particular area of regulatory affairs. In addition
we specialize in helping international manufacturers
and distributors obtain the FDA approvals necessary
to introduce their medical devices into the United
States market. |
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Maureen O'Connell
Regulatory Consultant
In 1997, Maureen O'Connell founded the firm
after a successful corporate career in
regulatory and clinical affairs. Prior to founding O’Connell Regulatory
Consultants, Inc., Maureen was Vice President,
Regulatory & Clinical Affairs for Summit Technology, Inc. Maureen was employed by Summit
from 1988 until 1997 in
a number of capacities
in Regulatory
and Clinical Affairs. |
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O’Connell, MA. “Understanding
Off-Label Use of Medical Devices and Drugs”. Medical Insight
February 2004; Volume 13, Number 2.
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Hersh, PS; Stulting, RD; Steinert, RF; Waring, GO; Thompson, KP;
O’Connell,
M; Doney, K; Schein, OD. “Results of Phase III Excimer Laser
Photorefractive Keratectomy for Myopia”. Ophthalmology 1997;
104; 1535-1553.
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Maloney, RK; Thompson, V; Ghiselli, G; Durrie, D; Waring, GO;
O’Connell, M. “A Prosective Multicenter Trial of Excimer Laser
Phototherapeutic Keratectomy for Corneal Vision Loss”. American
Journal
of Ophthalmology 1995; 119; 149-160.
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Maloney, RK; Chan, WK; Steinert, R; Hersh, P; O’Connell, M. “A
Multicenter
Trial of Photorefractive Keratectomy for Residual Myopia after
Previous Ocular Surgery”. Ophthalmology 1995; 102; 1042-1053.
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Waring, GO; O’Connell, MA; Maloney, RK; Hagen, KB; Brint, SF;
Durrie, DS; Gordon, M; Steinert, RF. “Photorefractive
Keratectomy for Myopia Using a 4.5-Millimeter Ablation Zone”.
Journal of Refractive Surgery 1995; 11; 170-180.
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