Practical Regulatory Affairs 2020 – US FDA Medical Devices

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

Created by: Pubudi Silva
Instructor

What Will I 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

Requirements

• No. A basic understanding of medical device regulations e.g. EU MDD or MDR would be useful, but is not necessary.

Target audience

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