Regulatory Submission Module 2: Setting the Foundation for Successful Approval

The regulatory professional can set the stage for submission success by understanding the technical, safety and quality needs of the new product to begin with. This module delves into topics such as intended use, predicate devices and substantial equivalence in order to discuss the resulting action steps needed to establish the most effective regulatory pathway.
 

Expert Faculty

Bill Brodbeck
Director, Regulatory Affairs
STERIS

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

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

Level

Intermediate
 

Learning Impact

Upon completion of this training, participants will:

  • Gain an appreciation for “understanding your product”
  • Build your submission around “The Big 3” (intended use, predicate devices, and substantial equivalence)
  • Stay a step ahead by having an action plan in place to address device classification and substantial equivalence discussions
  • Select the most effective regulatory pathway


Certification

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.

 

Price

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