BIO Professional Development

Through a curated network of education alliance partners, BIO offers industry professionals executive training and development resources for accelerating career growth

Medical Device Approval & Commercialization

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.

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Medical Device Approval & Commercialization Course Trailer


  • Choose the appropriate level of clinical trial based on risk assessment to the patient.
  • Explain the process of obtaining approval to initiate human clinical trials to test a new medical device.
  • List the challenges of launching a new medical device in terms of marketing, sales, reimbursement and manufacturing scale-up.
  • Outline a reimbursement strategy for coverage, coding and payment of a medical device.
  • Write a post-launch assessment and surveillance protocol.

Download Course Syllabus

Medical Device Approval and Commercialization Course Syllabus
Course Price:
$150 USD
BIO Member Price:
$120 USD
Course Length:
55 minutes
Course Level:
Completion Period:
2 weeks
Course Format:

Certificate Requirements

  • View the entire course
  • Pass course exam with a 70 percent
  • Complete the course evaluation
Suggested Prerequisites

Medical Device Overview and Regulation explores the diversity of the medical device industry by highlighting its various sectors, top companies and major regulatory bodies worldwide.

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Medical Device Development provides a detailed look at the five stages of medical device development including market opportunity evaluation, concept evaluation, engineering design, verification/validation and manufacturing transfer.

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