The Regulatory Process for Medical Device Approval

  • Course Price: $150 USD
  • Course Run Time: 57 minutes
  • Course Level: Level 2 - General
  • Completion Period: 2 week

The Regulatory Process for Medical Device Approval explains how medical devices are regulated in the United States. Medical device classification and each classification’s differing approval pathways are discussed in detail. FDA guidelines, quality system regulations, and risk management plans are also discussed in great detail. If you are new to the medical device industry, this class will provide an understanding of the breadth of the industry’s regulatory requirements.

Suggested Prerequisites

Diagnostics’ Role in Medicine Today

  1. Identify the medical device industry's major device sectors and worldwide regulatory organizations.
  2. Classify medical devices based on potential risks.
  3. Explain the major medical device approval pathways.
  4. Discuss how the Code of Federal Regulations and Good Practices enforces regulatory compliance.
  5. Develop a risk management plan for a medical device.
Certificate Requirements
  • View the entire course
  • Pass course exam with a 70 percent
Overview of Medical Device Types
Identifies the major medical device sectors and describes the history of medical device regulation.
FDA Medical Device Classification
Explains how to classify medical devices into Class I, Class II, or Class III based on risk assessment.
FDA Approval Pathways for Medical Device
Maps the medical device approval pathways, including how approval of a product can be obtained if a new device is being compared to a predicated device.
FDA Regulatory Compliance for Medical Device
Surveys various compliance laws including the Code of Federal Regulations, Good Lab Practices, Good Clinical Practices, and current Good Manufacturing...More
Medical Device Risk Management Plans
Demonstrates how to develop a risk management plan for a medical device.
Medical Device Regulatory Bodies Worldwide
Lists the worldwide regulatory bodies for medical devices.
Final Quiz
Certificate Requirements
  • View the entire course
  • Pass course exam with a 70 percent
You have two weeks from time of purchase to complete any of the online courses. For example, if you purchase the course at 9 am on Saturday, the course will close at 9 am 14 days later.

Our online classes are between 40 minutes and 85 minutes in length. We suggest allowing 20 minutes to take the end of the course quiz and 10 minutes to complete the class evaluation. 

Yes, each course has an accompanying pdf that contains all of the presented course information. 

There are no refunds once you have purchased an online course. 

The online classes are fully animated with a professional voice-over. Each course begin with an overview of what you will learn, the course itself, and then ends with a course quiz to assess your understanding.

You can repeat the class as often as you like within your two week run time.

You have two chances to pass the quiz. A passing score is 70% or higher. 

Each course is to be taken by one individual. If you would like to take our online courses as a group, please contact Stacey Hawkins at This email address is being protected from spambots. You need JavaScript enabled to view it. for pricing.

There are three requirements to receive your course certificate.

  1. You must view the entire course.
  2. You must pass the course quiz with a 70%.
  3. You must complete the course evaluation.

You can download and print your certificate from your dashboard only when all three of these items are completed. 

Before moving on to the next section of our on-demand, online courses, all slides within a section must be viewed.

There is an easy way for you to see which slides you have completed and not completed in the course. Look at the menu on the left side of the course- the slides that have been seen are darkened and the slides that have not been seen are light. 


BIO member discounts are available for on-demand, online classes. To access the BIO member discount, use your company email address during the checkout process. The checkout system will automatically recognize your organization and apply the 20% discount to your purchase if your company is a member of BIO. If you use a private email address we are unable to provide you the BIO membership discount.

If your on-demand course expires, but you have not completed it, you can extend it for an additional 2 weeks for $25.

  • Log into your dashboard
  • Go to the on-demand course you want to extend
  • The "Course Extension" button brings you to the payment gateway
  • Please note: It will appear you are being asked to pay the full amount of $150, but a discount will be automatically given once you fill in all of your payment information. 

You have 90 days, from the day your course expires, to take advantage of this nominal extension fee. Once the 90 days are past, you will need to pay the full price to view the course again. 

  1. Once your online course starts click on “Resources” in the upper right-hand corner
  2. In the drop down menu find the link “Course Slides”
  3. Download and/or print 
Certificate Requirements
  • View the entire course
  • Pass course exam with a 70 percent