DESCRIPTION
This course provides a basic introduction to medical devices and general aspects of product and regulatory lifecycles. It also provides a brief overview of the history of medical device regulation and information on basic regulatory principles and concepts as they apply to medical devices. Therefore, this course lays the foundation for a more in-depth study of medical devices and how they are regulated.
LEARNING OBJECTIVES
Upon completion, participants will:
- Define what is a medical device
- Describe how medical devices were regulated before the introduction of specific device regulations
- Describe how to classify a device
- Describe how the definition of a medical device is used to determine whether a product is a drug or device
- List important phases in the product lifecycle of a medical device
- List examples of different types of marketing authorizations
- Explain key difference between device quality systems and drug GMPs requirements
TARGET AUDIENCE
This program is designed for beginning regulatory affairs and quality assurance professionals.
Cost: Member $95; Nonmember $150
Type: Web-based Class
RAC Points: Participants receive 1 RAC point.
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, day or night, 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 1 hour 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.
Is 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 in the online course. However, RAPS does offer books on Ethics that you may find of interest as supplemental reading to the course, but they are not required texts and you may complete the course without them.