US FDA – Essentials of Regulatory Affairs for Medical Devices program

21 - 23 June
12:00 - 15:00

A two-part webinar
21st of June 12.00 – 15.00
23rd of June 12.00 – 15.00

The constant development of new medical devices, alongside changes and updates to regulations are paramount to this ever-changing and highly diverse field. Add in different regional requirements and companies can get lost very quickly. With the US market being a very lucrative market for many companies it is imperative that you gain the knowledge needed to succeed early in your process. This webinar series will give the foundation to tackle the US FDA guidelines.


Part 1:

21st of June 12.00 – 15.00

  • The U.S. Food and Drug Administration overview
  • Evolution of Requirements
  • Pre-Market Regulatory Processes

Part 2:

23rd of June 12.00 – 15.00

  • Approval and Clearance Processes
  • Post-Market Regulatory Processes
  • FDA Enforcement Activities

This is a free webinar series


  • Kami Faust (moderator)
  • Tony Blank


This series is in co-hosted by Regulatory Affairs Professionals Society (RAPS). The is the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals and biologics. RAPS is an independently funded, neutral, non-lobbying, non-political, not-for-profit organization that establishes professional standards (ethics, knowledge, skills, competencies, provides professional certification (Regulatory Affairs Certification, or RAC) and delivers education, training and professional development activities.

RAPS Profile By the numbers



Kami Faust

Regulatory Advisor - Norway Health Tech