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Program Description
This course provides a basic overview of in vitro diagnostic medical devices (IVDs) worldwide with focus on the US Food and Drug Administration (FDA). This course introduces key regulations and guidelines necessary for effective product development and explains the history of IVDs, development and testing, getting a product to market, product review, submission and harmonization.
Learning Objectives
Upon completion, participants will be able to:
- Discuss the current state of IVD regulations in the US and EU
- Identify and explain areas of IVD regulations related to:
- Product classification
- IVD development, testing and premarket submission
- Postmarket maintenance and considerations for users of your IVD product
- Identify potential future challenges facing IVD manufacturers
- Discuss IVD technologies and emerging trends
- Apply IVD-specific regulations and guidelines for successfully traversing regulatory hurdles
Target Audience
This is an introductory course designed for new and experienced regulatory affairs professionals interested in learning the basics of in vitro diagnostic medical devices regulations.
Cost: $200 member, $275 nonmember
RAC points: Participants receive 3 RAC points
Frequently Asked Questions
What is the time period of the course and when is the end date?
You will have 60 days to complete the course from the time of your purchase. The end date is calculated from your purchase date. You can complete the course work at any time that fits into your schedule. There is no pre-assigned time that you need to be online. It is a completely self-paced online course.
How many hours will it take to take the course?
It will take approximately three hours online to complete the course. This includes time for the final exam.
Is there any home work?
No, all the information you need to complete the course is included in the online course materials.
Are there any special computer requirements for access or software that must be downloaded?
RAPS Online University works best with an up-to-date version of IE explorer or Firefox. A current version of Flash is a common plug-in used in our courses. For your convenience, the URL to download this plug-in can be found at www.macromedia.com.
Is the purchase of any additional text required?
No, all the information needed to complete the course is included online. However, RAPS does offer books on EU regulations that you may find of interest as supplemental reading to the course, but there are no required texts and you may complete the course without any supplemental material.
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