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.

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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