Green Belt Certificate 20th Edition – Sept 2022

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  • This course closed on 10/09/2022.

Within this course, you will learn more about the EU MDR. But you will also be challenged. This is not only a course where you will get some theory but you’ll have also to show that you can put all the information into practice.

Course Information

Difficulty: Intermediate

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We recommend you engage in this course only if you have already some basic knowledge of EU MDR or if you have passed the Mini-Course EU MDR. You’ll need to invest 2-3 hours per day to be able to finalize the course, perform the quiz, work on the assignments, and participate in the Live Sessions.

Course Instructor

Monir EL Azzouzi Monir EL Azzouzi Author
  • Enrollment in this course opens on 17/08/2022.

Introduction

Let’s explain

Module 1 – General Overview

Regulatory Changes
Background
Timelines
GB20-M1 Live Session

Module 2 – Economic Operators

Economic Operators Overview
The responsibility of the Manufacturer
The responsibility of the Authorized Representative
The PRRC
The responsibility of the Importer
The responsibility of the Distributor
Summary on Economic Operators
GB20-M2 Live Session

Module 3 – Steps to go to market

3 Steps overview
Is this product a Medical Device?
What is the class of this Medical Device?
Which Conformity Assessment to choose?
GB20-M3 Live Session

Module 4 – Technical Information

Technical Overview
Technical Documentation
Clinical Evaluation
Post-Marketing Surveillance
PMCF
GB20-M4-Live Session

Module 5 – Traceability

Traceability Overview
UDI
EUDAMED
GB20-M5-Live Session

Green Belt Certification test GB20 

Green Belt Certification test GB20

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