Medical Device made Easy Podcast

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 Devi...

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

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 Azzou...

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

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...

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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 fir...