Medical Device Approval & Commercialization

  • Course Price: $150 USD
  • BIO Member Price: $120 USD
  • Course Run Time: 55 minutes
  • Course Level: Level 3 - Advanced
  • Completion Period: 2 week

Medical Device Approval and Commercialization explains the medical device approval process from initial regulatory submission through commercialization. Learn the diverse best practices accompanying a successful regulatory outcome, including manufacture scale-up, reimbursement strategy, product launch and post-launch assessment. If you are working in the diagnostics industry this course gives you a game plan to undertake a successful launch.

Suggested Prerequisites

Medical Device Overview & Regulation
Medical Device Development

Takeaways
  1. Choose the appropriate level of clinical trial based on risk assessment to the patient.
  2. Explain the process of obtaining approval to initiate human clinical trials to test a new medical device.
  3. List the challenges of launching a new medical device in terms of marketing, sales, reimbursement and manufacturing scale-up.
  4. Outline a reimbursement strategy for coverage, coding and payment of a medical device.
  5. Write a post-launch assessment and surveillance protocol.
Certificate Requirements
  • View the entire course
  • Pass course exam with a 70 percent
  • Complete the course evaluation
Trailer
Viewing Course Materials
Clinical Trials for Medical Device
Discusses how to choose the appropriate level of clinicial trial for a medical device based on that device's risk assessment to the patient.
Investigative Device Exemption (IDE)
Explains the process of obtaining approval to initiate human clinical trials, including how to identify a reference device and the importance of testi...More
Regulatory Submission for Medical Device
Reviews the time cycle for submission approvals.
Business Decisions for Medical Device Launch
Helps you think through the challenges of a product launch in terms of marketing, sales, reimbursement, and manufacturing.
Manufacturing Scale-Up for Medical Device
Highlights the challenges involved in scaling up manufacturing in preparation for product launch and lists the time cycle for manufacturing scale-up.
Reimbursement for Medical Device
Demonstrates how to outline a reimbursement strategy for coverage, coding, and payment.
Medical Device Product Launch
Lists the various pre-launch preparations and shows how to write a post-launch assessment and surveillance protocol. It concludes with a look at the m...More
Final Quiz
Course Evaluation
Certificate Requirements
  • View the entire course
  • Pass course exam with a 70 percent
  • Complete the course evaluation
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. 

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
  • Complete the course evaluation