O'Connell Regulatory Consultants, Inc. - Home

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.

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International device manufacturers can find it difficult to navigate the complex regulatory pathways necessary to access the United States healthcare market. O’Connell Regulatory Consultants specializes in helping international companies, particularly small and medium sized firms that may not have a dedicated regulatory affairs department.

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U.S. based distributors are often seeking new products to introduce into their product lines. In many cases, these products may not yet be FDA approved. O’Connell Regulatory Consultants can work directly with the international manufacturer and assist in preparing the necessary documentation which can then be sent to FDA in order to allow the new products to be FDA cleared. Once you have an approved product, it will be allowed through customs and can be legally sold in the United States.

510(k) Premarket Notifications
PMA Submissions
PMA Supplements for additional clinical indications or device changes
Investigational Device Exemptions (IDEs) for clinical trials
Combination Product Device Trials and Approvals
Managing Significant Risk and Non-Significant Risk Device Trials
Clinical Site Training and Monitoring
Labeling and Advertising Reviews
Company Registration and Device Listing
CDRH Electronic Product and Laser Reporting
Compliance and Custom Problems
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