Medical Device made Easy Podcast

Latest update will focus on IVDR proposal, Artificial intelligence, Notified Bodies situation and MDCG guidances. Other elements will also be discussed. I hope you'll enjoy! The post Medical Device News – November 2021 latest update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

BREAKING NEWS: The EU Commission issued a proposal to delay some IVDR date of application but it is not a complete postponment so don't use this word. Listen the interpretation of Erik Vollebregt on that. The post How does the EU Commission plan to save IVDR 2017/746? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

Ana Luiza is my guest and we will explain to you how to be sure that your are compliant with CMR substances on your product. CMR will be reviewed during an audit and apparently there were a lot of mistakes. So let's help you to avoid that. The post How to comply with MDR when products contain CMR Substances? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

EUDAMED is the database that will provide all the information about your company and your devices. After the release of the Economic Operator module, now there is the release of the Device Registration and Certificate Module. So let's talk about that with Richard Houlihan from Eudamed.com The post EUDAMED Update: Should you register your medical devices now? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

Here is the Regulatory update for October 2021. We will talk of the Implementation of MDR and IVDR, MHRA, Swissmedic, FDA, AEMPS.. A new session of the Green Belt opens this month. The post Medical Device News – October 2021 Regulatory Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

The MDR and IVDR has not finished to surprise us. On this episode we will talk about the article 16(4) where we see that in certain circumstances, an importer or Distributor will need to get certified by a Notified Body even if they are not doing a manufacturing activity. So don't miss that. The post Why does an Importer/Distributor need to appoint a Notified Body? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

Are you starting a clinical investigation or PMCF? Then are you using a Digital Solution to collect the data? Today we will explain to you what is The post How to collect Clinical Data within the 21st Century [Jon Bergsteinsson] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

We have passed the Date of application for MDR and this went well because a lot of manufacturers do have CE certificates that expire later. But for IVDR this is another story. So for the majority of the products, they should be compliant by the date of application. Let me explain that to you on this episode. The post How to manage the IVDR transition period? [IVDR 2017/745] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

Maybe some of dreamed of it, maybe this idea went through your mind but you haven't done it. Here we will talk with Erik Vollebregt of the consequences of opening a legal case with your Notified Body. The post Is it a good idea to sue my Notified Body? [Erik Vollebregt] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

On this September 2021 update we will talk about FDA, MHRA, Swissmedic, ANSM, Fimea, MDCG guidances, New Notified Bodies... A lot to talk about so don't miss this update. If you are not willing to read the guidances, let me summarize it for you. The post Medical Device News – September 2021 Latest Updates appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

There are a lot of questions about Software as Medical Devices. So I have invited Dr. Abtin Rad from TÜV SÜD to give us more information about how to consider SaMD with the EU MDR 2017/745 The post How to Certify a Software as Medical Device? (Dr. Abtin Rad – TÜV SÜD) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

This is a question I asked myself when I started my career. I am now an independant consultant but I started as a Full-time employee. So Smahan will help us understand which option can be the best for you. The post Better to be a Consultant or a Full-time employee? [Lifescience industry] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

We talked a lot about MDR and tried to teach most of its requirements. And today we will continue by providing you with the Most Common Mistakes that are discovered by Notified Bodies. Martin Witte from TÜV SÜD will share with us the issues that are discovered by its team. Let's learn from it. The post What can we learn from the first MDR audits? [Martin Witte -TÜV SÜD] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

This is already Mi-Year with the summer holiday. But EU Commission didn't sleep as there was a lot of MDCG guidance released. Let's review the agenda for this month and don't miss all the links. The post Medical Device News – August 2021 Regulatory Update [MDR & IVDR] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

Vigilance Reporting is an important system to have within your quality management system. Even if you are still MDD, you need to comply to the MDR requirements for it. So I will help you for that. The post How to implement Vigilance Reporting for MDR and IVDR? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

After receiving a lot of questions on System and Procedure pack we have decided to have a second episode on it with Erik Vollebregt. So let's review some special cases and also some feedback from the authorities. The post System and Procedure Pack the RETURN with Erik Vollebregt appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

Bassil Akra will help use interpret this first Expert Panel Opinion. Bassil already helped on a previous episode where we discussed about the creation of this Expert Panel. Let's review this first outcome and see the consequence of it for the industry. The post How to interpret the first Expert Panel Opinion? [Bassil Akra] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

We will update you on all what happened within the Medical Device regulation. All new The post Medical Device News: The July 2021 Update [MDR IVDR FDA SFDA] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

The State-of-the Art is one of the component that can make you win or make you lose. If this research is not done correctly, it can ruin your Clinical Evaluation Report or Performance Evaluation Report. Hakan Inan from Requalite will explain to us why this is important. The post How to build your State-of-the-art for your Medical Devices? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

In the case you are placing your brand trademark on a product, or if you buy a product designed by another company... then you need to understand the rules related to Intellectual properties. This episode with Stephen Carter will be a masterclass about Intellectual Property. The post How Intellectual Property is linked to the Medical Device Regulation? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

Clinical Investigation is not really an easy process. So it can be important for your to understand what are the requirements and get some details about time and cost. Helene Quie from Qmed Consulting which is also a CRO will help us learn more about this process required by EU MDR. The post How to perform a good Clinical Investigation with Helene Quie appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

This podcast episode is really important as this answers some of the questions that a lot of my customers are asking. So I hope this will help you to understand why this is important to perform a Biological Evaluation or Biocompatibility for your finished product. The post How to perform a Biological Evaluation for your Medical Device? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

Medical Device News June 2021 Update is providing you all the last updates. This IS the episode of the EU MDR date of application. A lot of news provided. The post Medical Device News – June 2021 Update [EU MDR Date of Application] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

EU MDR is starting tomorrow and we wanted to check the situation for Economic Operators. We had already interviewed Catherine on the previous survey release. This time we do a follow-up The post EU MDR Survey: What is the Industry’s opinion? [Catherine Higginson] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

1 week to the EU MDR and we hope that you are ready. If not, then you can maybe listen to this episode as we are answering some last minute questions. The post MDR is coming so brace yourself with Erik Vollebregt appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

This process called EUA was really famous last year when everyone wanted to register its face mask or respirator or covid-19 test in the USA. After 1 year let's see the conclusion of Michelle Lott on it. The post FDA: Is the Emergency Use Authorization worth it? (EUA) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

This is the last month before the EU MDR 2017/745 Date of Application. We will talk about that and about all the updates The post Medical Device News – May 2021 Update [EU MDR 2017/745] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

It is Day -30 for the EU MDR date of application. So let's summarize what should be ready for you and also what is not mandatory. The post Checklist – What is important before the EU MDR Date of Application? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

Merger and Acquisition is an important topic to understand as people think this is a fiance activity. But when you'll listen to this episode, you will not think that anymore. The post How to perform correctly a Merger & Acquisition during the MDR transition? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

IVDR is planned for May 26th, 2022 but why it will be more difficult for IVD manufacturers than for MDR manufacturers? Listen to this episode to have a better understanding The post Will it be really difficult for IVD manufacturers? [IVDR 2017/746] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

During the Greenlight Guru summit on EU MDR & IVDR I have presented the way to create a label. And following the session there was so many questions that I decided to answer to some of them within the Podcast so everyone can benefit from it. So I hope this will help. The post How to create a Label under MDR? (Questions & Answers) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

The system and procedure pack within EU MDR is still a mystery for a lot of people and Erik Vollebregt accepted to help us have a better understanding of this specific cases. We will explain to you what it is and who can use it. The post How System and Procedure Pack are regulated under EU MDR? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

In this episode, Edgar Kasteel will help us understand the role of an importer and will also tell us more about the model of independent importers. The post How to import your Medical Devices with an Independent Importer? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

In this monthly episode we will review what happened within the Medical Device industry. EUDAMED, Covid19, Notified Bodies... The post What is the Medical Device News? [March 2021 update] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

Waterfall or Agile? Jon Speer from Greenlight Guru will help to understand what is the best methodology that can be used to develop your medicaldevices. The post The best design methods for successful development? [Jon Speer] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

How to find a job in the QA RA world for Medical Devices? This is what we will discuss with Karandeep Badwal. We will provide our tips and also the platforms to visit. The post How to find a QA RA job for Medical Devices? [Karandeep Badwal] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

If you are thinking that you are the only one that has issues as QA RA, then listen to this episode. I hope this will help you to understand that there is a certain mindset to have when you do this type of job. The post What is the QA RA Mindset with Michelle Lott appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

On this podcast episode, we'll perform the February 2021 update. What happened in the Medical Device World. One of the HOT TOPICS is the Remote audit authorization by the EU Commission but we'll see this is not so easy. The post February 2021 Update – Medical Devices Remote Audit by the EU appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

PMS is an action that take some hours to perform. But with all the information generated, it get worse and worse. So I have invited Ivan Perez Chamorro, the Founder and CEO of Medboard to help us understand how we can love to perform PMS within our companies. Medboard has the solution. The post How to perform your PMS more easily with Ivan Perez Chamorro? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

The new EU MDR is now taking into account dangerous Software as a Medical Device SAMD. In this episode we will talk specifically about Artificial Intelligence Software. How to make them safe and efficient to be EU MDR certified? Listen to know. The post How to get the MDR certification for Artificial Intelligence Softwares? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

Liat Nadel is the CEO of L.S. Marketing & Registration. She will help us to understand the context for the registration of Medical Devices in Israel. The post How to register a Medical Device in Israel? (Liat Nadel) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

In this first episode of 2021 we provide you an update of the Medical Device Regulation situation. We will talk about Brexit, Swixit, Turkxit, MDCG, Notified Bodies, Approved Bodies, Trainings, Podcast... A lot to cover. The post Medical Device News – January 2021 Update (Monir El Azzouzi) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

This is the last episode of 2020 and I wanted to share with you the progress of the Easy Medical Device project. I will also tell you the next steps that I will try to achieve. Let me know how I can help you? The post How Easy Medical Device can help you? (Monir El Azzouzi) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

Martin Witte from TÜV SÜD will help us to understand the significant changes to your devices and the consequence of it for your CE Certificate. You will have to listen carefully if you are selling medical devices on the EU market after May 26th, 2021 under your EU MDD certificate. The post How to deal with Significant Changes within MDR & IVDR with Martin Witte appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

You maybe know how to register your devices in Europe or USA now. But let's discover how we can do that in Mexico with Josué Garza from IPS or Insumos para la salud. You'll learn the 3 pathways to do that. The post How to register a Medical Device in Mexico? [Josué Garza] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

This November update is providing a lot of information on what you should not miss. We will talk Brexit, Eudamed, Jobs, Training... A lot of topic to help you stay up-to-date. The post Medical Device News: What happened in November 2020? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

In this episode, we will hear the journey of a Notified Body to get EU MDR accredited. We hope this will help you to understand how difficult it is and why you should be patient with your Notified Body. The post Is it Easy for a Notified Body to get EU MDR accredited? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

In this episode, we will tell you why this is important to invest on trainings for your employees. I have invited a company that participated to the Green Belt Certificate and I asked them to tell us what they have implemented after taking this training. The post How a Quality & Regulatory training can help you? [Sofmedica] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

If you thought that clinical evaluation was already difficult to work on with the new EU MDR, then listen to this episode where we will tell you about the new level of difficulty that is coming soon. The post Do you need an Expert Panel for your Medical Devices? [Bassil Akra] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

Common Specifications are a type of regulation that we will explain to you in this episode with Stefan Bolleininger. The one on Reusable single use device was published. We expect more to come. The post What are Common Specifications under EU MDR & IVDR? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi