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Teaching & Academics
Fundamentals of US FDA Medical Device Submission Process
1.5-3hrs
beginner levelThe US FDA has enacted several regulations and policies for medical device manufacturers who wish to market their medical devices in the USA. Enrolling in this online course will familiarize you with the basics of this regulation and help you understand different marketing pathways. You will also get a brief orientation of ISO 13485 and 21 CFR Part 820, the standards required to establish a QMS in the medical device manufacturing industry.
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Fundamentals of US FDA Medical Device Submission Process
This free online course takes you to the path of medical device marketing in compliance with the US FDA regulations.
The US FDA has enacted several regulations and policies for medical device manufacturers who wish to market their medical devices in the USA. Enrolling in this online course will familiarize you with the basics of this regulation and help you understand different marketing pathways. You will also get a brief orientation of ISO 13485 and 21 CFR Part 820, the standards required to establish a QMS in the medical device manufacturing industry.
Course description
Course moduleA short ad will play before each lesson.
Module 15 Lessons
Understanding the Medical Device Marketing - The US Pathway
This module teaches you about the basic steps of medical device marketing within the US regulatory environment. You will also learn about the marketing pathways as defined by the US FDA and the premarket requirements before submission. The module also highlights the major differences between ISO 13485 and 21 CFR Part 820.
1.Learning Outcomes
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2.Steps in Medical Device Marketing
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3.FDA Marketing Pathways for Medical Devices
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4.ISO 13485 vs 21 CFR Part 820
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5.Lesson Summary
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Module 21 Lessons
Course assessment
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