The Month of May 2020 was supposed to be the beginning of the EU MDR. This was not as the new date is on May 26th, 2021. We will celebrate the Non-Anniversary of it and also talk about IVDR, MDCG, Notified Bodies, Coronavirus, Easy Medical Device podcast, LinkedIn Live... So be ready and push play. The post Medical Device News – May 2020 Review with Monir El Azzouzi appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
Jun 08, 2020•Transcript available on Metacast Sufficient Clinical Data is a new vocabulary introduced with the EU MDR 2017/745 but this is still unclear what is sufficient and what is too weak. Bassil Akra from QUNIQUE Group will explain to you what you should do in the episode where a former Notified Body employee is giving you advises related to his experience. Bassil is also offering a webinar to people that want to learn more about sufficient clinical data. The post What means Sufficient Clinical Data with Bassil Akra (EU MDR) appeared ...
Jun 01, 2020•Transcript available on Metacast If you are looking for a Notified Body for your Medical Device, you maybe have some difficulties to find one. In this episode, Bassil Akra from TÜV SÜD will explain to you the reason of this. The post What is the Notified Body situation? (Bassil Akra from TUV SUD) appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
May 25, 2020•Transcript available on Metacast I'll answer one of the most frequently asked question I receive from my followers. How to get ISO 13485 certified? Don't miss the links on the show notes to get more material to read. The post How to get ISO 13485 certified? (Quality Management System) appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
May 18, 2020•Transcript available on Metacast You are maybe a Digital Health Application developer, so this podcast will be of a great interest for you. If you don't place to make your device available in germany, than DIGA may help you change your mind. Listen to Stefan Bolleininger who will explain to you how your customers can get reimbursed. The post How to get your Digital Health Application reimbursed in Germany? (DIGA) appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
May 11, 2020•Transcript available on Metacast Medical Device News April 2020- We will talk about how Coronavirus is shaking the Medical Device World, the Notified Body Situation, the MDCG guidances and the Easy Medical Device events. Enjoy! The post Medical Device News – April 2020 Regulatory Update appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
May 04, 2020•Transcript available on Metacast Don't worry, we will not show you any equation for calculating the sample size. But we will show you how to do it and why you should be careful on some important parameters. Then you can see some examples in the ebook provided by Jon. The post How to calculate your sample size with Jon Bergsteinsson appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
Apr 27, 2020•Transcript available on Metacast This week there was an important vote regarding the proposal to delay the EU MDR until May 26, 2021. The parliament adopted it and we wait for the publication on the official journal. But what will be the consequence for Medical Device Manufacturers, Notified Bodies... The post The 1-year delay for the EU MDR 2017/745 with Erik Vollebregt appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
Apr 20, 2020•Transcript available on Metacast If you are not working in QA RA you maybe don't understand this. But sometime people don't want to follow the process not because they want to annoy you but because they are afraid of some consequences. And they try then to find other ways. Let's explore them with Karandeep Badwal The post Medical Device School – Why are Staff hiding problems to QA & RA? appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
Apr 15, 2020•Transcript available on Metacast Did you know that the EU MDR is amending 2001/83/EC for Medicinal Products. This may have some consequences for your products if it involves a Drug-Device combination. Monir El Azzouzi and Theresa Jeary are explaining to you what should be done. The post MDR & Drug-Device Combination Products with Theresa Jeary appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
Apr 13, 2020•Transcript available on Metacast The month of March 2020 is over but there was a lot of information provided regarding the Medical Device industry so let's listen to the different news with Monir El Azzouzi The post Medical Device News – March 2020 Review (EU MDR) appeared first on Medical Device made Easy Podcast . Monir El Azzouzi
Apr 06, 2020•Transcript available on Metacast 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•Transcript available on Metacast 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•Transcript available on Metacast 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•Transcript available on Metacast 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•Transcript available on Metacast 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•Transcript available on Metacast 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•Transcript available on Metacast 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•Transcript available on Metacast 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•Transcript available on Metacast 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•Transcript available on Metacast 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•Transcript available on Metacast 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•Transcript available on Metacast 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•Transcript available on Metacast 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•Transcript available on Metacast 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•Transcript available on Metacast 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•Transcript available on Metacast 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•Transcript available on Metacast 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•Transcript available on Metacast 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•Transcript available on Metacast 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•Transcript available on Metacast 
