Xavier Health
QA/RA Institute for Medical Device Professionals
 

Regulatory Submission Series


Download Summary of Regulatory Submission Series

Course Format:

  • Webinar

Expert Faculty:

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 will provide 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.

  1. Setting the Strategy for your Company’s Submission Process
  2. Setting the Foundation for Successful Approval
  3. Verification of the Foundation
  4. Constructing a Robust Submission
  5. Submission Review and Outcomes
  6. Post-market Submission Actions

 

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.

Course Certificates:

Each participant will receive a certificate of completion after each module attended upon the return of a completed evaluation form: Regulatory Submission Series Evaluation Form. Each participant will receive 0.1 CEU credits per hour of training.

Tuition:

Registrants may register for individual modules separately if desired. Select the module(s) of interest from the list provided above.

Industry: $1890.00
†Small Companies: $1485.00
†††Startup/Academic: $405.00
Government Official: $0.00

Attendee Types
† A Small Business is one that has less than 100 employees.

††† A Start-up Company is one that manufactures product. A start-up company who provides only services is not included in this category. The start-up company must not have product on the market yet, and therefore no revenue being generated. The start-up company has less than 10 employees.

Who Should Attend:

Regulatory Affairs Medical Device Professionals

Logistics:

Webinar session system and access requirements will be sent to participants prior to session date. For non-Webinar-attendees, sessions will be available via purchased recording after the Webinar date.