Meetings with the FDA or Other Regulatory Bodies

When conducting any FDA meeting, the goal is to obtain a clear response to the questions included in your meeting request, and leave with a clear understanding of the Agency's expectations. In order to accomplish these goals, punctilious planning and organization is essential and leaving the FDA with a positive impression of you and your device is critical. Conducting a flawless meeting requires the expertise of a professional. The Weinberg Group is the expert you need. We have a vast amount of knowledge and experience to ensure your FDA meeting is planned and executed as impeccably as possible.

Medical Device Meeting Services

The Weinberg Group's medical device-related FDA meeting services include:

  • Pre-Submission Meeting
  • Submission Issue Meeting
  • Informational Meeting
  • PMA Day 100 Meeting

To learn more about how Zi-Medical can help you develop a complete FDA, CFDA or other regulatory body submission for your medical device, IVD or other medical products, contact us today