Course Description

Steps to CE Mark

Course Description:

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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Learning Objectives:

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

Who Should Enroll:

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.

Prerequisite Knowledge/Requirements:

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

Subject Matter Expert:

52 min

Related resources:

Case studies:

Basic Account: € 154.00
Premium Account: € 115.00

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