Series Description

The regulatory professional serves a vital role in new product development for medical device companies. The ultimate goal of the regulatory professional is to successfully select the correct regulatory pathway for a new device, construct and file a robust submission, and proactively respond to FDA decisions—keeping patient safety and product effectiveness in mind throughout. The regulatory professional must also know how to quickly react to design changes and other post-market occurrences. This series provides the regulatory professional with the information and insights necessary to make these timely and important decisions to improve patient outcome and in turn support business success:

  • Setting the Strategy for your Company’s Submission Process
  • Setting the Foundation for Successful Approval
  • Verification of the Foundation
  • Constructing a Robust Submission
  • Submission Review and Outcomes
  • Post-Market Submission Actions
     

Expert Faculty

Bill Brodbeck
Director, Regulatory Affairs
STERIS

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

Ralph Hall
Counsel
Faegre Baker Daniels

Soma Kalb
Acting Director, IDE Program
FDA

Phil Phillips
President
Phillips Consulting Group

Marjorie Shulman
Director, Premarket Notification 510(k) Program
FDA

April Veoukas
Director, Regulatory Affairs
Abbott
 

Course Introduction

This six-part series serves as a “how to guide” for the regulatory professional with a focus on discussing the most important components of 510(k) submissions and working with FDA.
 

Who Should Attend

Regulatory affairs medical device professionals
 

Course Certificates

Each participant will receive a Certificate of Completion after each module attended upon the return of a completed evaluation form. Each participant will receive 0.1 CEU credits per hour of training. Access to webinar/s and link to the CEU evaluation form will be provided upon purchase.
 

Individual Modules

Price

Registrants may purchase all six modules at a 15% discount, or may purchase individual modules at $99 each using the links above.

$500 for entire series (includes a 15% discount for purchase of all six modules)

Government Official: $0.00 (must have valid .gov email account)