Biotech Primer Institute

Medical Device Approval & Commercialization

20 STUDENTS ENROLLED

Course Availablity: Unlimited views for 72 hours from time of purchase
Course Running Time:
55 minutes | Assessment: 20 minutes
Course Material: Downloadable PDF of all presented slides
Preview Now: Clinical Trials for Medical Device

Medical Device Approval & Commercialization explains the medical device approval to product launch process. This includes the business preparations, manufacturing scale-up, reimbursement strategies and product launch decisions that accompany a successful regulatory outcome. Post-launch assessments and post-market surveillance are also considered. Be prepared for a successful launch with this course.
Running time: 55 minutes | Assessment: 20 minutes

Clinical Trials for Medical Device
At the end of this section you should be able to:
1. Define Investigational Device Exemption (IDE)
2. Choose the appropriate level of clinical trial based on risk assessment to patient

Investigative Device Exemption (IDE)
At the end of this section you should be able to:
1. List the different types of IDEs
2. Explain the process of obtaining approval to initiate human clinical trials to test a new medical device
3. Understand how identifying and testing a new device against the reference device is crucial when seeking FDA approval

Regulatory Submission for Medical Device
At the end of this section you should be able to:
1. Explain the time cycle for submission approvals

Business Decisions for Medical Device Launch
At the end of this section you should be able to:
1. List the challenges of launching a new medical device in terms of sales and marketing, reimbursement, manufacturing

Manufacturing Scale-Up for Medical Device
At the end of this section you should be able to:
1. Explain the challenges involved in scaling up manufacture in preparation for product launch
2. List the time cycle for manufacturing scale-up

Reimbursement for Medical Device
At the end of this section you should be able to:
1. Outline a reimbursement strategy for coverage, coding, and payment

Medical Device Product Launch
At the end of this section you should be able to:
1. List the various pre-launch preparations that need to be completed
2. Develop a post-launch assessment and surveillance protocol
3. Convey which medical device reports are mandatory for the FDA

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