This is an important question if you understand the rule for a transition period of your device under EU MDR article 120(3). If you perform a significant change then you may be prepared for the consequences. Let's see what are the advice of Erik Vollebregt if you reach this situation. The post What is a Significant Change for your Medical Device? with Erik Vollebregt appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
Mar 30, 2020
In this episode we will focus specifically on Medical Device class I that are "Sterile", with measuring function" or "Reusable surgical instruments". Elem Ayne will help us to understand what you should prepare to be compliant. The post All about Class Is, Im and Ir with Elem Ayne (EU MDR 2017/745) appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
Mar 23, 2020
Do you recall those movies with hackers that are taking the control of an hospital or of your pacemaker. Is this Science Fiction or reality. On this episode, Monir and Erik will explain to you how to secure your medical devices if they are connected to a network. The post Cybersecurity for your Medical Devices with Erik Vollebregt appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
Mar 16, 2020
In this episode, we will talk about, Coronavirus, MDCG, Notified Body, US guidance, Podcast episodes, LinkedIn Live... So don't miss it. The post Medical Device Regulatory Update – February 2020 appeared first on Medical Device made Easy Podcast . Monir El Azzouzi
Mar 09, 2020
It is clear that a Manufacture of a Medical Device need to have a Quality Management System. But what is the answer for an importer, Distributor or Authorized Representative? You'll hear it on this episode where Erik Vollebregt will help us understand the requirements of the regulation. The post Do your Economic Operators need a Quality Management System? appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
Mar 04, 2020
The intended purpose of your device is critical but a lot of manufacturers are nor really putting much effort to write a good one. Check on this episode with Cesare Magri why this is important and how to create it correctly. The post Create your intended purpose with Cesare Magri (Medical Device) appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
Mar 02, 2020
Your Economic Operators do have some responsibility per EU MDR and IVDR. What should they check? Monir El Azzouzi and Erik Vollebregt will help you understand that on this bonus episode. The post Medical Device School: What should verify your Economic Operators? appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
Feb 26, 2020
Many medical device manufacturers try to solve a puzzle regarding their Low risk medical devices. How to write Clinical Evaluation for it without data? here is the solution. Download the presentation. The post Clinical Data for Low Risk Medical Devices with Robert van Boxtel appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
Feb 24, 2020
In this episode we will explain you the way that Economic Operators are controlled. This may seem obvious but the answer can be different per Economic Operator. So listen to this short episode of Medical Device School to understand everything. The post Medical Device School – Who controls your Economic Operators? appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
Feb 19, 2020
Brexit, Swixit, Turkxit. These are the topics of this episode of the Podcast. We will try to help you understand all these -XIT and what is the impact to Medical Device manufacturers. The post Are Brexit, Swixit, and Turkxit a reality? with Erik Vollebregt appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
Feb 17, 2020
Who are the Economic Operators mentioned on the MDR and IVDR? This is the question that Monir El Azzouzi and Erik Vollebregt will try to answer. The post Medical Device School – Who are your Economic Operators? appeared first on Medical Device made Easy Podcast . Monir El Azzouzi
Feb 12, 2020
Swixit or not Swixit? is an alert to Medical Device Manufacturers regarding the political game that is played between Europe and Switzerland. Let's see the impact for the Swiss market but also for the EU market. The post Swixit or not Swixit? this is the question with Ronald Boumans appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
Feb 10, 2020
Process Validation or Verification? Some people are mixing both concepts, this is why Monir and Stefan will help you understand when to use one or the other. The post Medical Device School – Process Validation or Verification? appeared first on Medical Device made Easy Podcast . Monir El Azzouzi
Feb 05, 2020
This episode will be dedicated to provide the regulatory updates that happened on January 2020. This will help you to stay up-to-date. The post Episode 61 – Medical Device Regulatory Update: January 2020 appeared first on Medical Device made Easy Podcast . Monir El Azzouzi
Feb 03, 2020
As Tania is saying this is the best time to export your products to Brazil, so we'll teach you how to register your products there. Enjoy! The post How to register your Device in Brazil with Tania Aprigliano? (ANVISA) appeared first on Medical Device made Easy Podcast . Monir El Azzouzi
Jan 27, 2020
Quality and Regulatory affairs is not really a job that everyone want to work in. But this is maybe you didn't listen to the right arguments. Check what Monir El Azzouzi and Karandeep Badwal want to say. The post Why is it Awesome to work in a Quality or Regulatory affairs job? appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
Jan 22, 2020
MDR is requiring to create a Quality Management System but how to do that. This is what you will learn with Monir El Azzouzi and Stefan Bolleininger. The post How to create a QMS compliant to MDR with Stefan Bolleininger appeared first on Medical Device made Easy Podcast . Monir El Azzouzi
Jan 20, 2020
Michelle Lott is my guest and will help us understand the 510k registration process with the US FDA. Should you use it? Is this changing? Learn everything in 1 episode. The post How to register your Medical Device through 510k with Michelle Lott appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
Jan 13, 2020
How should you audit your suppliers? Should you do the same as a Notified Body? Monir El Azzouzi and Stefan Bolleininger are providing you their opinion. The post Medical Device School: How to audit your Suppliers? appeared first on Medical Device made Easy Podcast . Monir El Azzouzi
Jan 08, 2020
PMCF is a key element of the Post-Marketing Surveillance process. As there were a lot of questions about it then I decided to ask Helene Quie some questions while I was at Medica 2019. The post Post-Marketing Clinical Follow-up with Helene Quie (PMCF) appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
Jan 06, 2020
This is the last episode of 2019 and I wanted to summaries the situation and introduce you to my 2020 projects. The post I wish you a Happy New Year 2020 with Monir El Azzouzi appeared first on Medical Device made Easy Podcast . Monir El Azzouzi
Dec 30, 2019
With the MDR, more and more clinical data are needed. But how will you collect them. David Rutledge will show you 6 ways to collect those data and the pros and cons for each of them. The post 6 ways to collect Clinical Data with David Rutledge appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
Dec 23, 2019
Before to look at this episode, you should go to Part 1. On this second part we'll continue to discuss Class I up-classified situation and then pure Class I devices under MDR. The post Class I Medical Devices under MDR with Erik Vollebregt (PART 2) appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
Dec 16, 2019
The MDR Corrigendum 2 is changing the rules for some class I devices under MDD that are up classified under MDR. Let's see what manufacturers should do. The post Corrigendum 2 – Changes for Class I Devices with Erik Vollebregt (Part 1) appeared first on Medical Device made Easy Podcast . Monir El Azzouzi
Dec 09, 2019
If you have a product and you want to evaluate if this is a Medical Device, then you need to follow the 3 steps that we will discuss on this episode. Heikki Pitkänen's platform is providing a solution for your to evaluate your device and he offers it for free to the listeners of this podcast. Thanks to him. The post How to evaluate your Medical Devices in 3 Steps with Heikki Pitkänen? appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
Dec 02, 2019
What is the role of a Distributor within the new MDR 2017/745 and IVDR 2017/746. This is the question that I asked my guest who is working as distributor of Medical Devices in Norway. The post Responsibility of a Distributor in MDR & IVDR with Nicolaj Nitzsch appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
Nov 25, 2019
When you are trying to create your product there is one question that you should answer: Should you focus on your product development or your documentation creation? Listen to our argument on this episode of the podcast. The post Medical Device School: Product Development or Documentation creation? appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
Nov 21, 2019
EUDAMED is delayed but what should do Medical Device manufacturers to continue be compliant. Richard Houlihan is a EUDAMED expert and will help us understand. The post EUDAMED is delayed, so What? with Richard Houlihan appeared first on Medical Device made Easy Podcast . Monir El Azzouzi
Nov 18, 2019
When creating your Clinical Evaluation Report or CER, you maybe need to perform a literature search. There is a certain method for that and we wanted to help you to understand it with Ed Drower from CiteMedical Solution The post Literature Search for your CER with Ed Drower appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
Nov 11, 2019
In this Bonus episode of Medical Device School we will talk about Gap Assessment tools. You know that when there is a regulation or something that you should put in place, you need to perform a gap assessment. To check where you are and if you are compliant to where you want to be. Let'S see if you follow our discussion with Stefan Bolleininger. The post Medical Device School: How to build a Gap Assessment Tool? appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
Nov 07, 2019
