FDA Consultants

Company Description

FDA Consultants team of dynamic professionals who have years of experience working in the medical device industry and have helped a number of domestic and foreign companies meet FDA requirements and obtain approvals for their medical devices.

We keep abreast of latest developments in the US medical device regulatory environment and advise our clients on best practices which allow them to adapt to the ever changing requirements of the FDA.

Unlike most consulting companies which offer a wide range of services to their clients, we focus on what we feel are the most important areas for companies to start marketing their products in the USA.

Company Information

  • Contact Person:Mr. FDA Consultants
  • Telephone:
  • Zip:11790
  • Province/State:New York
  • City:Stony Brook
  • Business Type:Agent, Business Service (Transportation, finance,
  • Year Established:2003
  • Trade Capacity:North America : 16.67% Southeast Asia : 16.67%
  • Production Capacity:- -
  • Main Products:FDA Consulting, 510k Consulting, Quality Assurance Consulting, Product Management, Medical Device Listing, FDA Related Services,
  • Address:2188 Nesconset Highway
  • Main Markets:North America, Southeast Asia, Eastern Asia, Weste
  • Location:New York, United States
  • Website:Visit website

Product

  • US Agent Services
  • Establishment Registration and Device Listing
  • 510(k) Pre-market Notification (PMN)
  • Quality Management System (QMS) for Medical Devices
  • Standard Operating Procedures - SOPs
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