Delphi Consulting Group (DCG)

WORLD WIDE

   U.S. Agent

Your Source for US FDA Medical Device Release to Market

Home of the DCG iSubmission and iDocuments

Houston, Texas USA Based, Worldwide Service

Established in the year 1988

Experience Matters.

Telephone + 832-675-9281  -6 GMT, or James.Knauss@delphiconsulting.com

Regulatory Assistance with medical devices and the U.S. FDA and Health Canada.

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ASSOCIATE GROUPS

COOPER CONSULTING SERVICE (CCS)

Established in 1986.  Medical Device design, prototype and testing regulatory services.

Cooper Consulting Service (CCS) has a broad range of engineering capabilities.  We have designed numerous medical devices, ranging from teaching products to critical care systems.  Our services are tailored to client needs and can range from turn-key product design to supporting a specific aspect of design or test.  Working with CCS puts 100+ years of engineering experience on your team!

CCS is committed to our customer’s success and has worked with companies large and small, from all over the world.  Our team wants to help you bring your product from concept to commercial success!

Check out this CCS document: click here

Contact:

www.cooperconsultingservice.com  or phone +281-482-9786

DCG provides U.S. Agent services and/or Official Correspondent to medical device manufactures located outside of the U.S. and import into the U.S.   DCG meets all FDA requirements as listed below.  

Any foreign establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a device imported into the United States must identify a United States agent (U.S. agent) for that establishment.

Information about a foreign establishment’s U.S. agent is submitted electronically using the FURLS system and is part of the establishment registration process. Each foreign establishment may designate only one U.S. agent. The foreign establishment may also, but is not required to, designate its U.S. agent as its official correspondent. The foreign establishment should provide the name, address, telephone and fax numbers, and e-mail address of the U.S. agent.  Contact harvey@delphiconsulting.com.

Responsibilities of a U.S. Agent
The U.S. agent must either reside in the U.S. or maintain a place of business in the U.S. The U.S. agent cannot use a post office box as an address. The U.S. agent cannot use just an answering service. They must be available to answer the phone or have an employee available to answer the phone during normal business hours. DCG is ready to answer the telephone 8 to 5 CST US, Monday through Friday.

The responsibilities of the U.S. agent are limited and include:

Assisting FDA in communications with the foreign establishment, responding to questions concerning the foreign establishment's devices that are imported or offered for import into the United States, assisting FDA in scheduling inspections of the foreign establishment and
if FDA is unable to contact the foreign establishment directly or expeditiously, FDA may provide information or documents to the U.S. agent, and such an action shall be considered to be equivalent to providing the same information or documents to the foreign establishment.
Please note that the U.S. agent has no responsibility related to reporting of adverse events under the Medical Device Reporting regulation (21 CFR Part 803), or submitting 510(k) Premarket Notifications (21 CFR Part 807, Subpart E).

 Please note that we do NOT provide FDA Agent representation for FOOD companies.

Send mail to  harvey.knauss@gmail.com for questions or comments about this web site.
Copyright © 2019 Delphi Consulting Group
Last modified: 06/13/2021

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