General Information
| Topic of the Course | Unique Device Identification |
| Course Duration | 3- 3,5 hours |
| Type of Course | e-Learning, Online & Self-Paced |
| Course Material Available | No |
| Transcript Available | No |
Course Contents
Section 0 – General Introduction to the Course
Course Description and Duration
Structure of the Course
Objective of the Course
Assessment of Learning AchievementsPrerequisite and
Course Certificate
Section 1- Introduction to the UDI System
Definitions
Structure of the UDI System
The UDI elements: Device Identifier, Production Identifier, UDI Carrier, Units of Use.
Section 2 – UDI & Quality Management System
UDI Implementation Plan
UDI and QMS Processes
UDI and Change Management
UDI & Economic Operators
Verification and Validation of UDI Carrier System
Section 3 – How to Build a UDI System: Practical Information
Basic UDI -DI
How to Build the UDI Coding System
UDI Carrier and Barcode System
Example of Label with UDI System
UDI & Packaging Configurations
UDI & Medical Device Software
UDI and Reusable Devices
UDI for SAMD Devices
UDI for Implantable devices
General Information
General Description
This online & Self-Paced Training Course is focused on the management of Unique Device Identification (UDI), according to the requirements of EU MDR 2017/745 and IVDR 2017/746. For a more detailed description of the course, refer to the section related to the course contents.
Who Should Attend the course?
This course should be followed by anyone focused on the implementation of the UDI system, willing to have an overview of the UDI requirements and practical suggestions for UDI implementation.
Course Access
During payment process, your account will be created. You will receive an email with a link to access your account area. Training courses can be attended only after user account creation.
Structure of the Course
This course is divided into four different sections. At the end of each session, there are some tests and exercises aimed at consolidating the information related to each part of the course. At the very end of the course, a final test shall be performed.
Course Certificate
At the end of the course, upon successful completion of all the intermediary and test. Each test shall be passed with a minimum score of 70%.
Prerequisites
No specific prerequisites are requested to attend this course. However, general knowledge of ISO 13485 and EU MDR / IVDR would be beneficial, although not mandatory or requested.
