Delphi Consulting Group

Category: Regulatory  

Summary:

James Harvey Knauss has years of experience in assisting companies with the regulatory maze associated with export and import of medical devices. He is listed with the FDA as a "United States Agent for Devices" as defined in Section 417 of the Modernization Act of 12997, for foreign companies that market medical devices in the United States.

Full Description:

• Preparation and filing of Premarket Notifications [510(k)} and 513g's for medical devices.
• Preparation and filing of Premarket Approval (PMA) applications.
• Assistance in connection with misbranding and adulteration holds by the FDA.
• Assistance with labeling, advertising issues and informed consent agreements.  Assistance with drafting of protocols, informed consent forms, and related documents necessary for the filing of Investigative Device Exemption (IDE) applications.s
• Assistance with FDA recalls or market withdrawals fo products.
• Assistance during FDA GMP enspections. Drafting replies to FDA Form 483, listing of Addverse Finding and Warning letters.
• Writing and production of medical device operators and service3 manuals that reduce product risk and satisfy FDA requirements.
• Providing US Agent services for offshore manufacturers.

Source:

Website: http://www.delphiconsulting.com

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