Steps to CE Mark
This course walks learners through the different steps of the path to CE-mark including classification system and routes to CE-mark based on an efficient quality system and adequate technical file.
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Upon successfully completing this course, learners will be able to:
- Illustrate the CE-mark process and its major components
- Understand how classification systems under the medical device directive work
- Determine how manufacturers decide which CE-mark route is appropriate for a particular device
- Recognize the importance of a well-designed quality system
- Comprehend technical files and the differences with STED as a global system
Professionals new to the medical device industry, including inventors, managers, CEOs, or business professionals needing to understand the elements of the CE-mark process are all encouraged to participate in this course.
The following material is required:
- Understanding what constitutes a medical device
- How to determine if a product is considered a medical device
- Understanding the different phases of the medical device lifecycle