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OCONNELLREGULATORY.COM

O'Connell Regulatory Consultants, Inc. - Home

O’CONNELL REGULATORY CONSULTANTS-20 years experience in medical device regulatory and clinical affairs. FDA approvals include 510(k)’s, IDEs, and PMAs.

http://www.oconnellregulatory.com/

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CONTACTS AT OCONNELLREGULATORY.COM

OConnell Regulatory Consultants, Inc.

Maureen OConnell

5 Ti●●●●Lane

Nort●●●●ding , Massachusetts, 01864

United States

ma●●●●●●●●@mindspring.com

View this contact

OConnell Regulatory Consultants, Inc.

Maureen OConnell

5 Ti●●●●Lane

Nort●●●●ding , Massachusetts, 01864

United States

978-●●●●1245
ma●●●●●●●●@mindspring.com

View this contact

OConnell Regulatory Consultants, Inc.

Maureen OConnell

5 Ti●●●●Lane

Nort●●●●ding , Massachusetts, 01864

United States

ma●●●●●●●●@mindspring.com

View this contact

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O’CONNELL REGULATORY CONSULTANTS-20 years experience in medical device regulatory and clinical affairs. FDA approvals include 510(k)’s, IDEs, and PMAs.
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2 FDA
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international device manufacturers,us based distributors,510 k premarket notifications,pma submissions
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O'Connell Regulatory Consultants, Inc. - Home | oconnellregulatory.com Reviews

https://oconnellregulatory.com

O’CONNELL REGULATORY CONSULTANTS-20 years experience in medical device regulatory and clinical affairs. FDA approvals include 510(k)’s, IDEs, and PMAs.

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1

O'Connell Regulatory Consultants, Inc. - International

http://www.oconnellregulatory.com/international.html

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. Helpful guidance documents and.

2

O'Connell Regulatory Consultants, Inc. - Home

http://www.oconnellregulatory.com/index.html

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. 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.

3

O'Connell Regulatory Consultants, Inc. - About Us

http://www.oconnellregulatory.com/aboutus.html

In 1997, Maureen OConnell 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 and 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. O’Connell, MA. Understanding. Off-Label Use of Medical Devices and Drugs . Medical Insight. February 2004; Volume 13, Number 2.

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O'Connell Regulatory Consultants, Inc. - Services

http://www.oconnellregulatory.com/services.html

Here is a list of the services that we provide:. 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. Once a Class III devi...

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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. 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.

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