Practical Regulatory Affairs 2020 – US FDA Medical Devices

Practical Regulatory Affairs 2020 – US FDA Medical Devices, available at $69.99, has an average rating of 4.43, with 25 lectures, 1 quizzes, based on 921 reviews, and has 2920 subscribers.

You will learn about Learn about US regulations for medical devices, and the role of the FDA Understand the various regulatory pathways available for medical devices in the US Learn how to practically use the various FDA tools and databases to determine the required regulatory route Discover how to navigate the FDA website to find more relevant information for specific devices This course is ideal for individuals who are Junior Regulatory Affairs professionals or Engineers with medical device experience or Physicians/Professors with device ideas or Medical device project team members It is particularly useful for Junior Regulatory Affairs professionals or Engineers with medical device experience or Physicians/Professors with device ideas or Medical device project team members.

Enroll now: Practical Regulatory Affairs 2020 – US FDA Medical Devices

Summary

Title: Practical Regulatory Affairs 2020 – US FDA Medical Devices

Price: $69.99

Average Rating: 4.43

Number of Lectures: 25

Number of Quizzes: 1

Number of Published Lectures: 25

Number of Published Quizzes: 1

Number of Curriculum Items: 26

Number of Published Curriculum Objects: 26

Original Price: €34.99

Quality Status: approved

Status: Live

What You Will Learn

Learn about US regulations for medical devices, and the role of the FDA
Understand the various regulatory pathways available for medical devices in the US
Learn how to practically use the various FDA tools and databases to determine the required regulatory route
Discover how to navigate the FDA website to find more relevant information for specific devices

Who Should Attend

Junior Regulatory Affairs professionals
Engineers with medical device experience
Physicians/Professors with device ideas
Medical device project team members

Target Audiences

Junior Regulatory Affairs professionals
Engineers with medical device experience
Physicians/Professors with device ideas
Medical device project team members

From the authors of the leading EU Medical Device Regulations course on Udemy, we now present Practical Regulatory Affairs 2020 for US FDA Medical Devices.

The US is one of the worlds leading medical device markets, with a unique regulatory framework. Being able to navigate the US regulatory landscape is a crucial skill for anyone interested in working in regulatory affairs, or anyone looking to bring a device to market in the US. This course focuses on the practical application of regulatory tools and pathways available through the US FDA, using real-world examples and exercises to help you understand not only the regulations themselves, but how to effectively comply with them. Wherever possible, we provide you with relevant links and information from the FDA itself to guide your understanding in each module.

Written and developed by a group of Regulatory Affairs professionals currently working in industry, this course focuses on the most common issues and questions we receive from medical device manufacturers looking to enter the US market.

Course Curriculum

Chapter 1: Introduction

Lecture 1: Introduction

Chapter 2: FDA Scope and Code of Federal Regulations

Lecture 1: The Food and Drug Administration

Lecture 2: Code Of Federal Regulations

Lecture 3: Medical Device Definition and Scope

Chapter 3: Device Classification

Lecture 1: Device Classification Basics

Lecture 2: Device Classification Examples and Excercise

Lecture 3: Device Classification Exercise Answers

Chapter 4: FDA Regulatory Pathways

Lecture 1: Regulatory Pathways

Chapter 5: FDA Pre-Market Notification [510(k)]

Lecture 1: Basic Overview of the 510(k) Process

Lecture 2: Concept of Substantial Equivalence

Lecture 3: Intended Use vs Indications for Use

Lecture 4: Identifying a Predicate Device

Lecture 5: Substantial Equivalence Workflow

Lecture 6: 510(k) Structure

Chapter 6: 513(g) Mechanism

Lecture 1: 513(g) Mechanism

Chapter 7: De Novo Submission

Lecture 1: Overview of De Novo Submission

Lecture 2: Basic De Novo Strategy

Chapter 8: Pre-Market Approval (PMA)

Lecture 1: PMA Submissions

Lecture 2: FDA Cleared vs FDA Approved

Chapter 9: FDA QSR and Post-Submission Requirements

Lecture 1: FDA QSR

Lecture 2: Submission Costs

Lecture 3: Post Submission Process and Timelines

Lecture 4: Device Registration and Listing

Chapter 10: Emergency Use Authorizations (EUA)

Lecture 1: Basic EUA Overview

Chapter 11: Final Tools

Lecture 1: Final Tools

Instructors

Pubudi Silva
Instructor

Rating Distribution

1 stars: 6 votes
2 stars: 16 votes
3 stars: 87 votes
4 stars: 369 votes
5 stars: 443 votes

Frequently Asked Questions

How long do I have access to the course materials?

You can view and review the lecture materials indefinitely, like an on-demand channel.

Can I take my courses with me wherever I go?

Definitely! If you have an internet connection, courses on Udemy are available on any device at any time. If you don’t have an internet connection, some instructors also let their students download course lectures. That’s up to the instructor though, so make sure you get on their good side!

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