The Main Concepts for Safe and Performing Devices
Course Description:
This course reviews how regulators define safe and performing (or effective) medical devices. It includes an outline of the most essential EU directive requirements, the importance of risk management systems, and what clinical evaluation means.
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Learning Objectives:
Upon successfully completing this course, learners will be able to:
- Comprehend how essential requirements, risk analysis, and clinical evaluation interrelate to create an efficient quality system in support of all activities
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 courses are required:
- The Lifecycle of Medical Devices from Idea to Market (ID 159)
- Creating Value in Healthcare (ID 175)
- What is considered a Medical Device? (ID 161)