DESCRIPTION
This course provides a basic understanding of medical device regulation in the European Union. It reviews the history of medical device regulation and follows the regulatory requirements through the lifecycle of the product. It will discuss how devices are classified and how this effects its labeling, registration and listing, and post-market requirements. It is beneficial for beginning RA and QA professionals.
LEARNING OBJECTIVES
Upon completion, participants will:
- Classify medical devices in a European framework
- Recognize the unique features of the European regulatory framework
- Identify the unique features of preclinical and clinical testing in Europe
- Outline the conformity assessment pathways to obtain CE marking
- Discuss postmarketing requirements
TARGET AUDIENCE
This program is designed for new regulatory affairs professionals and others in related departments interested in understanding the basics of the regulation of medical devices in the EU.
Cost: Member $275; Nonmember $350
Type: Web-based Class
RAC Points: Participants receive 4.5 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, 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 4.5 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.
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 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.