Introduction to FDA and Notified Bodies

Overview of the expectations of the FDA and Notified Bodies

Introduction to FDA and Notified Bodies

Lesson 1: Welcome

About this course

This is an introductory course on the FDA and notified bodies.

In this course we will discuss:

  • FDA regulations
  • EU Regulations
  • Developing a regulatory strategy
  • Preparing a submission

At the end of the course, complete the course quiz for your records.

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() lessons in this course

Welcome
Introduction
U.S. Regulations - Food and Drug Administration (FDA)
U.S Regulations - CRDH
EU Regulations - Notified Bodies
Standards
Regulatory Strategy
Preparing for a Submission
The Submission
Commercialization
Conclusion

Welcome

Welcome to Introduction to the FDA and Notified Bodies course .

In this course we will talk about regulations, regulatory strategies to prepare for your submission.

On the right you'll see the sections we'll cover in this course and you can download the course slides as a reference.

Let's get started!

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