Practical Regulatory Affairs 2020 - US FDA Medical Devices

Practical Regulatory Affairs 2020 - US FDA Medical Devices

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.

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

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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

Rating: 4.5

Level: Beginner Level

Duration: 1.5 hours

Instructor: Pubudi Silva