Green Belt Certificaite

Thanks for choosing the Green Belt Certification Program. Below you can have a view of the planned session. Please pick a session and enroll in it.

Available Sessions

2024

March 2024 - 30th Edition

March 25th until March 29th

May 2024 - 31st Edition

May 27th until May 31st

June 2024 - 32nd Edition

June 24th until June 28th

If you have any questions about this training, then don’t hesitate to ask us. info@easymedicaldevice.com

Program

The EU MDR 2017/745 is the new legislation that replaces the EU MDD 93/42/EC and the AIMDD 90/385/EEC.

In this course, we will focus on helping you understand the requirements of the EU MDR. During 5 days, you will follow the different chapters and guidances that are important for your training. Below are the different topics for each day.

General Overview

During the first day we will review the global situation of the EU MDR with its history, timeline and also the Significant changes that can change the timeline.

This will include also the changes that happened during 2023 with the vote of the extension of the transition period.

You will also have to perform an assignment on understanding the consequence of a Significant Change.

Economic Operators

There are multiple economic operators and it is important to understand what everyone should do and what they should not do also.

In this module, we will also talk about the PRRC or Person Responsible for Regulatory Compliance. 

There are multiple questions that we receive on Economic Operators and in this course, we have already prepared an FAQ that will then answer them.

On the assignment side, we will ask you to explain the different roles and responsibilities of each economic operator.

3 Steps to Market

You may ask yourself where to start when you need to comply to the EU MDR. If you already have your products, you need to define your strategy and for that you have to answer 3 questions:

  • Is my product a Medical Devices?
  • What is the classification of my product?
  • How can I place my product on the market?

During this module, we will also talk about the selection of the Notified Body. So I will explain to you which criteria should be looked at and which database is used for that.

Technical Information

This module is really heavy as we will talk about technical data. We will cover:

  • Quality Management System
  • Technical Documentation with GSPR
  • Clinical Data with clinical evaluation and clinical investigation
  • Post-Market Surveillance
  • Post-Market Clinical Follow-Up

The objective here is not for you to be an expert on all this but to understand how all this is connected. When you need what and what is affecting what…

EUDAMED and UDI

These are the new tools created by the EU MDR and IVDR. So during the course I will help you navigate through the EUDAMED database and then you’ll learn to create a UDI code and  the BASIC UDI-DI.

Testimonials

Great information from the lecturers, right amount of information and happy that I booked the course.
Icon testimonial female
F Batiao
Medical Device
The course was very well done to provide detailed information and present it in multiple ways to learn. The 5 day packed lessons presented the information so that at the end of the week I understood the regulation requirements.
Icon testimonial female
J Lundquist
Medical Device
I would really recommend this course. As you might have noticed through his podcasts already, Monir is really talented in explaining concepts and teaching. This course dived into the considerably deeper concepts of EU MDR that could really challenge you. Monir did a great job in designing the assignment to really give you the chance to apply those concept. He is also very responsive to questions too, and support you along the way. Furthermore, there are some really great guest speakers during the live sessions that could really give you something new and gives you the opportunity to ask questions and potentially form networks. Overall, for me, in my goal to transition to the medical device regulatory affairs, I find this course has inspired me further alongside some fundamental concepts of the EU MDR.
Icon testimonial male
J H Pang
Medical Device
I strongly recommend this course for those working in the MedTech industry. The course is well structured, provides important and deep information on MDR with some training and all the Live Sessions are very useful. Last but nor the least, Monir provides all the information and support needed.
Icon testimonial male
T Veloso
Medical Device
The time invested during the live classes, the assignments and quizzes were very helpful to me to get a better understanding of the MDR requirements. If you are unfamiliar with the MDR this is a worthwhile class to take.
Icon testimonial female
B Rinaldi
Medical Device
Monir El Azzouzi is the consummate professional and expert in medical devices and the EU MDR, and one of the best instructors for courses on those topics. Even his complimentary (free) material and regular podcasts are quite valuable. He is knowledgeable, accessible, and interested in the success of his students. His courses, products, and services are all highly recommended. The live sessions of the Green Belt Certification were most beneficial.
Icon testimonial female
P Smart
Medical Device
This course offered to the participants in a very structured manner lot of updated information easy to understand, a very pleasant learning experience enhanced by the daily asignments and quizes and good interactivity with the lector. Thank you Monir!
Icon testimonial female
C Miroescu
Medical Device
The course is very informative, and every day I was learning a new thing, you made it an easy medical device
Icon testimonial female
M Abel
Medical Device
Before this course I had a basic knowledge of the MDR. Monir was able in only 5 days (plus a little bit of week end study) to teach me all the basics and more. I really enjoyed the course and the practical approach that was used to address all the topics. Definitely recommend!
Icon testimonial female
C Grullero
Medical Device
It is very obvious Monir has an in-depth understanding of the MDR.
Icon testimonial female
F Gibbons
Medical Device
I am a Quality Engineer, working for a Dental products manufacturing Company in US. My major responsivity is to be incompliance to new MDR and all the regulatory requirements for US and Canada. I am familiar with only FDA regulations, MDR is new to me. When I was browsing the Web for information, I found a lot of valuable podcast from Monir. I took his free mini course and got the certification as well. I admired his passion towards providing the information to cover all the topics in the new MDR to the world. I appreciate Monir for helping and answering to those who need clarity. Just by reading the MDR regulation, there is no way we can do our job right. I feel stress free after taking this Green Belt Certification course, because lot my questions have been clarified and also Monir is willing to clarify any further questions in future. Monir is so quick in responding to email. Monir is a great resource to the regulatory world by bringing all the experts and providing updated information. I just want to thank Monir for the amazing work he is doing.
Icon testimonial female
M Maithili
Medical Device
Working in a manufacturing company that supplies parts to medical device manufacturers it is important to realize what MDR compliance requirements we have. The green belt certification offers enough information to realize when we need to comply with the MDR and if so what we need to comply with.
Icon testimonial male
B Leijendeckers
Medical Device
As a person with a business background, I would honestly say the training might be tough during the whole week, especially from Module 3 to Module 5, but it would be useful to know more about the latest EU regulation and have a chance to see the whole picture of the regulatory compliance in the medical device industry. The instructor's support is helpful, so don't be shy to ask him any questions!
Icon testimonial male
K Wang
Medical Device
Dear Monir and colleagues, thank you very much this instructive, intensive Course. I understand and improved my basic knowledge in MDR area.
Icon testimonial female
A Letic
Medical Device
Monir has an expert knowledge of the EU MDR 2017/745. The level of information provided in this course is excellent, breaking down the most important aspects into understandable terms. I would highly recommend this course to personnel in Quality and Regulatory fields along with Project Mangers facing the new MDR.
Icon testimonial female
R Coffey
Medical Device
For me, taking the MDR Green Belt Certification course felt like deciphering a secret code: everything started to make sense; and the pieces of the puzzle began to settle naturally one by one.
Icon testimonial female
R Paslaru
Medical Device