Regulatory Submission Module 4: Constructing a Robust Submission

This module will take the participants through the required 510(k) sections of the submission process, while pinpointing the challenges and pitfalls typically encountered by regulatory professionals. The intricacies of the submission process will also be explored with the participants.

Expert Faculty

Barbara Fant
President and Principal Regulatory Consultant
Clinical Research Consultants, Inc.

(Expert faculty titles and companies may have changed since the time of recording.)



Learning Impact

Upon completion of this training, participants will:

  • Distinguish the required sections of the 510(k) and successfully construct and submit the document to FDA
  • Identify common and atypical challenges before they become pitfalls
  • Navigate the FDA submission process, including eCopy


Certificate of Completion: Each participant will receive a Certificate of Completion for .1 CEUs upon viewing the webinar course and returning a completed evaluation form.



$99 per module
$500 for entire series (Receive a 15% discount for purchasing all six modules)