Practical Regulatory Affairs - US FDA Medical Devices

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Offered byUDEMY

Practical Regulatory Affairs - US FDA Medical Devices
at
UDEMY
Overview

A practical course discussing the US FDA Medical Device regulations for real-world situations

Duration	2 hours
Total fee	₹360
Mode of learning	Online
Credential	Certificate

Practical Regulatory Affairs - US FDA Medical Devices
at
UDEMY
Highlights

Earn a Certificate of completion from Udemy
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Practical Regulatory Affairs - US FDA Medical Devices
at
UDEMY
Course details

Who should do this course?

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

What are the course deliverables?

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

More about this course

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 participants understand not only the regulations themselves, but how to effectively comply with them
Wherever possible, we provide them with relevant links and information from the FDA itself to guide their understanding in each module

Practical Regulatory Affairs - US FDA Medical Devices
at
UDEMY
Curriculum

Introduction

Device Classification Basics

Device Classification Examples and Excercise

Device Classification Exercise Answers

Regulatory Pathways

Basic Overview of the 510(k) Process

Concept of Substantial Equivalence

Intended Use vs Indications for Use

Identifying a Predicate Device

Substantial Equivalence Workflow

510(k) Structure

513(g) Mechanism

Overview of De Novo Submission

Basic De Novo Strategy

Practical Regulatory Affairs - US FDA Medical Devices
at
UDEMY
Faculty details

Pubudi Silva

Medical device and Regulatory Affairs professional currently working in industry. Over eight years of experience in medical devices with expertise in EU, USA and global medical device regulations for a range of device areas including orthopaedics, cardiovascular devices and other active implantable devices. Seasoned trainer delivering courses and educational material to medical device professionals looking to expand their knowledge and skill-sets.