Medical Device made Easy Podcast

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 Medic...

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 D...

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...

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 Po...

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 Po...

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...

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...

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