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Oconnell Regulatory Conslnt Headquarters

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O'Connell Regulatory Consultants, Inc. - Home

    http://oconnellregulatory.com/
    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.

O'Connell Regulatory Consultants, Inc. - Contact Us

    http://www.oconnellregulatory.com/contact.html
    O’CONNELL REGULATORY CONSULTANTS-20 years experience in medical device regulatory and clinical affairs. FDA approvals include 510(k)’s, IDEs, and PMAs. To find out more information about our services please call us at 978-207-1245 or email us at [email protected] .

O'Connell Regulatory Consultants, Inc. - About Us

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

O'Connell Regulatory Consultants, Inc. - Services

    http://www.oconnellregulatory.com/services.html
    O'Connell Regulatory Consultants has significant expertise in filing successful 510 (k) applications for diagnostic and therapeutic Class II products in ophthalmology, dermatology, plastic surgery, vascular surgery, wound care, and other specialties. back to top. The most novel and most complex technologies are classified by FDA as Class III ...

O'Connell Regulatory Consultants, Inc. - International

    http://oconnellregulatory.com/international.html
    O’Connell Regulatory Consultants specializes in helping international companies, particularly small and medium sized firms that may not have a dedicated regulatory affairs department. The consultancy can determine the required regulatory submission and prepare that submission for you. The majority of medical devices are cleared by the FDA ...

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