Let’s explain

Thanks for your interest in this Green Belt Certification dedicated to The Medical Device Regulation 2017/745. This will be an interesting journey for you.

I created this Certification program to provide you some basis of the EU MDR 2017/745 legislation. During all week, I will be with you to facilitate this journey. So if you are already an expert on EU MDR, a lot of the things mentioned will be maybe a repeat for you. But I am sure you will still learn something.

For each module, I will invite you every day to a Live Session where we will review the topic of the day and I will answer your questions. To define the best time for each student regarding the live session, I will send you a survey when the registrations will be closed. The time slot with most of the votes will be chosen. For those that will not be able to attend the Live Session, this one will be recorded so you can access it afterward.

For each lesson, a Quiz will be provided. This Quiz is only for training purposes. You will need to reach 80% to consider that you understood the content of that module.

Additionally, I will provide you with some assignments. These assignments are exercises that will help you put into practice what you learned and how to implement them in real life.

To be efficient, I ask you to read each course and look at each material I provided to help you understand the EU MDR. My objective is for you to learn something in the end.

Some people asked me what is the workload for this training week and after the 1st Edition, I can say that you need to invest an average of 2-3 hours per day. So please, reserve some time on your calendar.

After all the modules are completed you will be asked to perform the Certification Exam. This is a time-limited exam with only 1 attempt. You should perform that within the last 3 days after the last module is over.

If you succeed with a score higher than 80%, you will get your Green Belt Certificate. If you fail, you will receive a Certificate of attendance to the course. The challenge for you is to complete all this within 1 week.

Please consider this Week of training seriously as there will be some investment that you’ll need to provide.

Let’s introduce the course now.

The main topic

The EU MDR 2017/745 is a major change to the Medical Device Regulation in Europe. This is why you need really to be able to understand it. In this certification program, I will provide you with some material but you need to make your research and ask your questions.

To be able to get this certificate, you’ll need to understand the major requirements of the EU MDR. The objective is not for you to be considered as the absolute expert but to be able to understand the different aspects of it and explain them to another person.

At the end of this Journey, I will send you a Green Belt Certificate with my signature. This means that I certify that you passed all the tests with a score higher than 80%. This also means that Easy Medical Device is keeping this certificate for you on its folders and if any organization is interested to verify that you passed the certification they can contact us. We can disclose to them with your permission your different scores for each module.

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The Green Belt EU MDR 2017/745 Certification Program

Today I propose you to learn on a high level the key aspects of the MDR 2017/745.

  1. Module 1 – Overview
    1. Overview
    2. Regulatory Changes
    3. Background
    4. Transition Timeline
  2. Module 2 – Economic Operators
    1. Overview
    2. The responsibility of the manufacturer
    3. The responsibility of the Authorized Representative
    4. The responsibility of the Importer
    5. The responsibility of the Distributor
    6. Bonus: The PRRC
    7. Summary of Economic Operators
  3. Module 3 – Steps to go to Market
    1. Overview
    2. Is this product a Medical Device?
    3. What is the class of this Medical Device?
    4. Which Conformity Assessment to choose
  4. Module 4 – Clinical Evaluation – Technical File and PMS
    1. Overview
    2. Clinical Evaluation
    3. Technical Documentation
    4. Post-market Surveillance
    5. PMCF
  5. Module 5 – UDI and EUDAMED
    1. Overview
    2. Unique Device Identifier (UDI)
    3. EUDAMED
  6. Easy Medical Device Certification
    1. QUIZ with a certificate of completion 

Be careful, the Quiz will include some questions related to the Video or Material that is described in the course.

Infographic Green Belt EU MDR 2017/745 certification program

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