Introduction

“Howdy, I am here to introduce you to the course content and additional resources provided to students. My name is Matthew Walker, and that officially makes me your Medical Device Academy ‘Welcome Matt’! Awful pun aside, below is the course Table of Contents that will introduce you to the intended lessons of this training. In addition, below the Table Of Contents is the native slide deck for the training. If you attended the live webinar, you may notice that the videos provided throughout this training differ slightly from the full native recording. That is because the topic sections have been edited for clarity and continuity. For example, video cards might be seen to clarify points and provide additional details, and promotional date-sensitive information has been removed.

Table of Contents

  • Overview of the ‘new’ Canadian Regulation SOR/2020-262 (In force 12/23/21)
  • How to prevent missing future regulatory changes from Health Canada
  • How to prepare a Quality System Plan for implementation of the new regulation SOR/2020-262
  • How to prepare a Post-Market Surveillance Summary Report
  • How to document updates to the Risk Management File including the Benefit/Risk Analysis
  • When you must notify the Health Canada Minister of Health of changes to the Benefit/Risk Analysis conclusion and Implementation Action Items
  • Final Question and Answer period from the live webinar
  • Final Test

Additional Resources

Don’t Forget to Click on the “Mark Complete” Button Below!