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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Takeaways
- 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
Certificate Requirements
- View the entire course
- Pass course exam with a 70 percent
- Complete the course evaluation
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