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Keep Your Worldwide Product
Sales Alive and Well!
Conforming to medical device regulations is critical
to the successful marketing of medical products.
Ensure your company's conformance to current and
new regulations.
McLean Medical and Scientific, Inc., offers the following services:
Compliance Consulting:
Medical Device Directive (MDD)
In Vitro Diagnostic Directive (IVDD)
U.S. Food & Drug Administration (FDA)
510(k) Devices
Pre-Market Amendment (PMA) Devices
Investigative Device Exemption (IDE) Devices
Audit Assistance with FDA
Services:
US Agent (FDA)
Authorized Representative
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