This lecture presents the new European regulation for medical devices and provides an easy to learn overview of all the key changes. Learn all you need to know for a successful transition to the new legislative framework.
MDR for Dummies
- Course Type: Video Lessons
- Language: English
- Level: Beginner
- Session: year 2021
- Time: 0 - 1 Hour
|Introduction and Meditrial Tools||00:01:35|
|MDR for Dummies||00:02:27|
|Learn and Comply||00:06:57|
|When to be ready||00:05:39|
|Impact on Industry||00:03:00|
Exam and Certifications
- Final Test – MDR for Dummies
What I will learn?
- MDR Structure and Key changes to the Regulation
- MDR Scope and Definitions
- Responsibilities and obligations of Economic Operators
- EUDAMED and UDI
- Device classification and Conformity assessment
- Clinical evaluation and investigations
- Surveillance and Vigilance
Skills I will gain
This course will help you:
- Understand the principles, framework and procedures described in MDR
- Learn the scope and definitions followed by economic operators
- Learn how MDR regulates the manufacturing and marketing of medical devices in the EU
- Understand clinical evaluation and investigations along with surveillance and vigilance of medical devices.
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