Product Risk Classifications

Overview of how products are classified based on their Risk level

Product Risk Classifications

Lesson 1: Welcome

About this course

In this course we discuss how products are classified by the FDA and notified bodies.

In this course we will review:

  • How products are classified
  • Various product classifications
  • How to determine your product's risk classification

At the end of the course, complete the course quiz for your records.


Support

Email support@enzyme.com for any questions or feedback.

Course length
Effort
Price

Frequently asked questions

Is the Enzyme Community free to join?

Yes! There is no cost to join the Enzyme Community, but we'll soon be rolling out a number of premium features, available to Enzyme eQMS users or to those with subscriptions to the Enzyme Community.

Sign up now
How can I get access to eQMS related content?

Enzyme's eQMS content is reserved for eQMS subscribers. If you're interested in learning more or need to upgrade your account, please contact us.

Request access
What's the Enzyme Community all about?

Enzyme's Community offers educational content designed to teach you the ropes of regulatory compliance, quality management, and Enzyme's own eQMS, as well as opportunities for professional certification.

The Enzyme Community also offers specialized content for members like job postings, supplier intelligence data, and access to support documents and forums.

Find out more
How can I become certified?

Enzyme offers certification opportunities for those looking to level up their career and professional marketability. Contact the Enzyme team to find out how to get started on your certification.

Enzyme Certifications

Course instructors

Course collaborators

No items found.

() lessons in this course

Welcome
Introduction
Class I Devices (Low Risk)
Class II Devices (Moderate Risk)
Class III Devices (High Risk)
Summary
Conclusion

Welcome

Welcome to the Product Risk Classifications course!


This course is an overview of how to classify your product based on its level of risk. We also discuss the type of rigors and controls required by the FDA and notified bodies.

Let's get started!

This is some text inside of a div block.
No items found.

Course instructors

Provided in partnership with

No items found.

This course

Other courses

Resources

Enzyme Certifications
Slack Community
Enzyme Blog
Job Board
Enzyme Community content is updated continually to provide you the best product. If screenshots or videos are out of date or you get stuck, please contact us.
Ready to level up? Inquire about certification.
info@enzyme.com or

Ready to do more?