Medical Device Approval and Commercialization

  • Course Price: $150 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 medical device sector, this course gives you a game plan to undertake a successful launch.

Suggested Prerequisites

The Regulatory Process for Medical Device 
Medical Device Development

Takeaways
  1. Choose the appropriate clinical trial level based on the patient's risk assessment.
  2. Explain the approval process to initiate human clinical trials to test a new medical device.
  3. List the challenges of launching a new medical device in 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
Download Agenda
Certificate Requirements
  • View the entire course
  • Pass course exam with a 70 percent
Trailer
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
Certificate Requirements
  • View the entire course
  • Pass course exam with a 70 percent