Medical Device made Easy Podcast

What is IEC 62304? This is the question I asked Adnan Ashfaq from Pharmi Med Ltd. The answer is helping a lot to understand the interaction with other standards and regulations. Enjoy it! The post Understand IEC 62304 for Medical Device Software with Adnan Ashfaq appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

Team-PRRC is invited to this episode to help us understand how to become a PRRC. This is a new role required for Medical Device manufacturers. In this episode, we will also share with you what TEAM-PRRC can do to help you. The post How to become a PRRC with TEAM-PRRC (EU MDR & IVDR) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

During this update, we will talk about the Coronavirus situation, the Notified Body accredited, the CEN CENELEC mandate for Harmonized Standards, the Green Belt Certification Program. A lot to say and also a Trailer for the EU Commission Telenovela. The post Medical Device News – June 2020 Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

Shokoufeh from Straumann in Switzerland is sharing with us her journey on the EU MDR world. She will tell us what helped the team to reach this success and what she would have changed. The post The secrets to being EU MDR certified with Shokoufeh Khodabandeh appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

Process Validation is an important but difficult topic. You should not only be good at engineering but also at explaining to your staff. Because a good validation worth nothing if the Staff is not following the instruction. Listen to Monir El Azzouzi and Adnan Ashfaq sharing with you their experience. The post How to perform your Process Validation with Adnan Ashfaq (IQ OQ PQ) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

In this episode, I will help you understand the power of Internal Audits. Some of you are using that just because ISO is requiring it but you can get so much out of it. The post How to execute your Internal Audits? (Medical Device companies) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

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

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 first on Medical Device made Easy Podcast. Monir El Azzouzi

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

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

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

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

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

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

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

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

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

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

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 Azzouzi

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 Podcast. Monir El Azzouzi

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 first on Medical Device made Easy Podcast. Monir El Azzouzi

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

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

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

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

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

After episode 47 on how to implement an eQMS, Jacob Sjorslev is now telling us how to validate an eQMS. This is something mandatory now since ISO 13485:2016. So listen carefully and download the giveaway, The post How to validate an eQMS with Jacob Sjorslev appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

An eQMS can be a necessary tool for your Quality Management System. This is why it's implementation should be executed as a project. Jacob Sjorslev will be your instructor and tell what to do and what to avoid. And Jacob will also make you an offer at the end of the episode. The post How to implement an eQMS with Jacob Sjorslev appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

On the Medical Device School segment, we will help you understand how to be better with your CAPA system. Stefan Bolleininger and Monir El Azzouzi are sharing with you their experience. The post Medical Device School – Most important issues on your CAPA (ISO 13485) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi