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.
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.
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.
Registrants may register for individual modules separately if desired. Select the module(s) of interest from the list provided above.
Who Should Attend:
Regulatory Affairs Medical Device Professionals
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.