This lecture describes the key changes regarding post market surveillance and what companies should do to meet their new obligations. After the course you can take a final test to receive your certification. Enjoy!
The New European UDI System Part I
$49.00
- Course Type: Video Lessons
- Language: English
- Level: Advanced
- Session: year 2020
- Time: 0 - 1 Hour
Course Breakdown
| Section | Time |
|---|---|
| Introduction | 00:02:29 |
| MDR References & UDI Purpose and Benefits | 00:01:50 |
| UDI Components | 00:02:42 |
| Basic UDI-DI and Unit of Use DI | 00:03:26 |
| Information to be entered in EUDAMED | 00:05:52 |
| MDR Timelines for registration of device data in EUDAMED | 00:00:45 |
| Correlation table between MDD and MDR | 00:00:50 |
| UDI in Europe vs the USA | 00:07:11 |
Exam and Certifications
- Final Test – MDR The New European UDI System (Part I)
- Certification
Description
What I will learn?
This course will highlight the UDI system and will facilitate easier traceability of medical devices and quick identification of the specific user. This system significantly enhances the effectiveness of the post-market safety-related activities for devices and allow for better monitoring by competent authorities.
Skills I will gain
- Discover Unique Device Identification (UDI) System
- Explore the UDI structure and requirements
- Learn key the timelines for registration of device data for EUDAMED
- Understand the difference between UDI in Europe vs the USA
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