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EUDAMED Commission implementing regulation 2021/2078: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32021R2078 EUDAMED webpage: https://ec.europa.eu/health/md_eudamed/udi_devices_registration_en EUDAMED Playground: https://webgate.training.ec.europa.eu/eudamed-play/landing-page#/ UDI/Devices guidance: https://ec.europa.eu/health/sites/d…
 
Recently the MDCG guidance for Medical Device classification was published. And I wanted to have someone to help us decode it. Frank Matzek accepted to share his knowledge as he worked on the consultation of this guidance and he can tell us if there are some specific elements to look at. The discussion of today will be mainly on the changes related…
 
One of the most stressful situations in the medical device business is the selection and the work with Notified Bodies. Why? Because there are less than what we need and because it is difficult to budget their service. So I have invited the Head of the TÜV SÜD Healthcare Business Unit to tell us more about the Notified Body Situation. We will discu…
 
If you are a company buying products from a supplier and then putting your brand on it to sell it in Europe, then you are an Own Brand Labeller or Private Labeller, or Virtual Manufacturer. In this episode, we will discuss this business model and what are the options for you as this is not really possible under EU MDR 2017/745 or EU IVDR 2017/746. …
 
We always think that what is most important in QA RA is to know the regulation. NO!. What is most important is to be able to transmit this knowledge to the other colleagues within your company. But to do that you need to understand certain parameters and this is what we will discuss today with Lesley Worthington. This podcast will help you improve …
 
In this episode of the Podcast we will review: IVDR proposal to delay transition periods Cobalt on medical devices as CMR Artificial Intelligence MDCG guidance Notified Body overview Check links below Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years wit…
 
A few weeks ago, we were surprised to hear that the EU Commission issued a proposal to delay some products from applying IVDR 2017/746 by my 26th, 2022. So we decided to discuss this proposal with Erik Vollebregt and see how this should be interpreted as this is not a postponement that is proposed but more some phase application per product class. …
 
In this episode, we will discuss CMR which are some substances that can be dangerous for your health. They are classified by legislation and we will explain to you what you should do. Ana Luiza Cassin Duz, Clinical Specialist will help us to define what are the MDR requirements and how you can follow the rules and be compliant. In a previous episod…
 
Recently EUDAMED made a major Update which was the release of the Device registration module. This is something that all Medical Device manufacturers need to listen to as this may impact their workload. Richard Houlihan from Eudamed.com accepted to come and tell us more about this update and provide you also with some advice on how to manage it. So…
 
Here are all the topics that we will cover during this regulatory update. Don’t forget to contact easy medical device if you need an EU-authorised representative, a Swiss representative or a UK-responsible person. HOT TOPIC Implementing Rolling Plan: https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_rolling-plan_en.pdf EUROPA IVDR e…
 
Recently MDCG issued the guidance on Article 16 of the EU MDR & IVDR. This provided some surprises. So now in certain circumstances, some importers or distributors will need a Notified Body for their products. Erik Vollebregt from Axon Lawyers will explain to us those cases and why this is important that importers and distributors are becoming on t…
 
Clinical Data is key for the Medical Device Regulation MDR 2017/745. Today on this Podcast Episode, I have invited Jon Bergsteinsson from Smart Trial. And we will discuss Digital tools to collect data. History of Clinical Data Collection Difference between Big and small companies Use of CRO for collecting data Difference on Clinical Investigation a…
 
We are at 9 months of the EU IVDR 2017/746 date of application. So let’s t talk of the Transition period for such products. We have done that also for MDR 2017/745 when the date was nearly due. So today we’ll tell you about: Differences between IVDD 98/79/EC and IVDR The Hard Transition Period – The Soft Transition Period The UDI transition period …
 
First of all, I am not encouraging anyone to sue anyone. This is only educative content to know what is possible and what is the best strategy to do it. We will talk about the reason one company would sue its Notified Body and also about the good method and the bad method to do it. Some of the discussions are based on real-life experience. Anyway, …
 
This month we will cover a lot of specific rules that are applied in some countries: USA UK France Finland Switzerland And then we’ll look at Events planned, Notified Bodies, MDCG guidances released, and the Podcast episodes. Enjoy! Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs. A…
 
Software as a Medical Device is really a difficult topic. First, because it is quite new in the EU Regulation, and second because we cannot make a generality and should consider each software one by one. In this episode, we asked directly a Notified Body to tell us exactly how we should view this field and what are the tips or warnings. So I have i…
 
Let’s describe to you the life of a Healthcare industry consultant with Smahan Toughrai. Within this episode, we will ask the question like: Why would we choose a consultant job? Should people have a certain skill to be a good consultant? Is the salary a good motivation to be a consultant? Is it better to work for a small company or a multinational…
 
After few months of MDR, I proposed TÜV SÜD share with us the most common mistakes they find during their audits. And Martin Witte accepted to summarize some of them. So in this episode, you will hear the TOP 3 issues that are discovered so you can be prepared for it. You will see that some of them are obvious and others are more subtle. Administra…
 
On the agenda for this month Episode we will talk about the latest news and here are few topics that I will present to you: Team-NB Position Paper Harmonized Standards Free ISO standards MHRA guidance on Software as Medical Devices Training EU MDR Green Belt in August Notified Bodies situation MDCG guidances Easy Medical Device Podcast episodes Don…
 
Within this Masterclass, I will explain to you how to implement a vigilance reporting system with all the links for all the documents we talk about. Vigilance reporting is a system that you need to have in place for your Quality Management System even if you are still MDD compliant. If you get a serious incident or a Field Safety Corrective Action …
 
In this second episode on System and Procedure Pack, we answer more questions about this way to place devices on the market. Erik got some experience with the authorities that he will share with us and I have created some cases that I will propose to Erik and see how he would manage them. Erik will also talk more about IVDR as this is a topic of hi…
 
We received the First Expert Panel Opinion and by reading it you can say a lot. So to help us have a good interpretation of it, I have asked Bassil Akra to be my guest on this podcast episode. We will remind you what is the Expert Panel, then we’ll discuss more deeply the Opinion received and finally, we will provide you some advice on how to avoid…
 
In this episode of the podcast, we will provide an update on the Medical Device industry for the period June July 2021. Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and particularly Johnson and Johnson, he decided to cre…
 
State-of-the Art is an important topic but not well understood. It’s why I have invited Hakan Inan from Requalite to help us get a better understanding of this concept that you should use on your Clinical Evaluation or Performance Evaluation. We will talk not only about MDR but also about IVDR as this concept is required for both. Don’t hesitate to…
 
In this episode of the podcast, I wanted an expert to answer the question about IP related to Medical Devices. A lot of people are willing to understand how intellectual property works when for example: We have a Private Labeling Business When we buy a product already designed by another company but place it on the market under your name? When we w…
 
Clinical Investigation is one of the toughest process within the EU MDR 2017/745. If you have to perform one for your Medical Devices then it can be a long and expensive process. In this episode, Helene Quie from Qmed Consulting, will help us understand how to perform it in a good way. This episode will answer some of the questions you have about C…
 
We talked a lot about the regulatory requirements for your Medical Devices. Now let’s talk about something more technical which is the Biological Evaluation following ISO 10993-1 or also called Biocompatibility. This is something that is key for the Medical Device Manufacturers but it is also not well understood. So Ana Luiza Cassin Duz, a Clinical…
 
Ok, this month the EU MDR is LIVE so we will talk about that. The date of application for EU MDR 2017/745 was May 26th, 2021 and there is a lot of information that I will share with you. We will talk about EU MDD bye bye party Webinars EU MDR impact on other countries Swixit Turkxit IVDR 2017/746 Notified Body Situation MDCG guidance IMDRF guidance…
 
Last year we had reviewed the result of the EU MDR Survey made by Climedo and this year we check the difference. Do you think that there will be a big change? Climedo has decided to ask questions related to the EU MDR but also to the context due to Coronavirus. So we are now looking at the result and you’ll see that there are some changes. But stil…
 
MDR is coming In 1 week and before that, I asked Erik Vollebregt from Axon Lawyers about some questions that I receive. We will talk about: – EU MDR IVDR postponement or not? – Economic Operators date of application – PRRC do we need it from day 1 – Exclusion from EU MDR – OEM OBL rules from May 26th, 2021 And Erik announces the content of its book…
 
In this episode of the Podcast, we will explain to you what is the Emergency Use Authorization (EUA) that can be started in the US. And to help us, I have invited Michelle Lott from Lean RAQA. This process was used a lot recently for Coronavirus products but you will see with Michelle that this process was changed so many times that it can create s…
 
Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the worl…
 
Wahoo!! We are close to it now. The EU MDR 2017/745 Date of Application is arriving quickly. So for this episode, I wanted to check with you if you are ready. I will provide you first with the Scope for this date. Which products have to be ready by May 26th, 2021. Then we will talk about the documents that should be available. This list may not be …
 
Subscribe Merger and Acquisition sound like a financial topic but you’ll see that all the ways lead to Quality and Regulatory Affairs. In this episode, Erik Vollebregt, Partner at Axon Lawyers will be helping us to understand why you should have some Quality and Regulatory affairs knowledge when you are running a Merger and Acquisition with a Medic…
 
Subscribe We talked a lot about the EU MDR and the difficulty for some manufacturers to transition to this new legislation. But today we will explain why IVDR manufacturers will struggle more. I will explain to you the change in terms of product classification within the IVDR 2017/746. Because of this, a lot of manufacturers that didn’t need a Noti…
 
Subscribe This podcast episode is following a presentation I have made during the Greenlight Guru Summit on EU MDR and IVDR. I have explained how to create a label that fulfills the requirements of the EU MDR. I have placed on the show notes the link to it. After the session, I have received a lot of questions and I didn’t have the time to answer a…
 
Subscribe Let’s discuss System and Procedure Pack. We usually talk about medical devices like as an object that is used in the healthcare industry. But when you have to combine multiple objects, how can you then regulate that. Is there one classification for all or should you classify and register each of them. And what if all these objects are alr…
 
Subscribe With the EU MDR 2017/745 and IVDR 2017/746 the role of Economic Operators is becoming clearer. In the case you are located outside of Europe and you need to import your Medical Devices in the EU, you need to have an Importer. In this episode we will talk of the importer role and what they need to check before your product is placed on the…
 
Subscribe This month we will review what happened within the Medical Device Industry and there was some updates. Here is the agenda: EUDAMED Covid19 Language for EU MDR 2017/745 MHRA virtual manufacturer update Australia Nanoparticle consultation Singapore Medical device grouping tool Saudi Arabia covid 19 update Easy Medical Expert Green Belt Trai…
 
Subscribe I am really honored to have within this episode of the Podcast Jon Speer. I was already following him before I started Easy Medical Device and now I had the opportunity to interview him. We discussed Medical Device Design, and I wanted his opinion on the best design methodology to use and which trap to not fall in. We discussed particular…
 
Subscribe If you find it difficult to get a job in QA RA for Medical Devices, then listen to this episode where Monir El Azzouzi and Karandeep Badwal are giving you some tips on how to integrate this world. They will provide you some tools to use, some podcasts to listen to, some groups to follow. And for sure this will move you few steps forward. …
 
Subscribe Michelle Lott and I are discussing our Experience in the Quality and Regulatory affairs area. We will help you define what is compliance and how we think it should be applied. Michelle had also some good and bad experiences that she is sharing with us. Who is Michelle Lott? Michelle Lott is the founder and principal of leanRAQA, which has…
 
Subscribe In this monthly episode of the podcast, we do a regulatory intelligence review of what happened monthly. The agenda for this month is: Countdown until EU MDR by Michelle Lott (LeanRAQA) Remote Audit authorized for EU MDR SURVEY Result US update on Recognised Consensus Standards Canada guidance on Vigilance Reporting Training available Not…
 
Subscribe PMS is one of the processes that is changing due to EU MDR and I wanted to come back to it with Ivan Perez Chamorro from MedBoard. MedBoard is a solution that helps you with your Regulatory Intelligence. And Ivan is trying to make the life of the companies easier by providing some tools. In this episode, Ivan will first explain to us what…
 
Subscribe Artificial Intelligence. This is the topic of today’s podcast episode. We will help you understand how to place AI Software as a Medical Device in the EU Market with the new EU MDR 2017/745. For that, I have with me Leon Doorn from Aidence who is explaining to us its journey to get EU MDR 2017/745 certified. You will first understand what…
 
Subscribe Registration of products in different countries is always a Challenge. And for Israel, this is the same. I have invited Liat Nadel from L.S. Marketing & Registration to help us understand the situation and how to succeed in the registration process. We will talk also about the possibility to use registrations already done in Europe and th…
 
Subscribe HAPPY NEW YEAR 2021 and all my best wishes to you and your family. Within this Medical Device News monthly episode of the podcast, we are reviewing the situation on: Brexit and the need for UK Responsible person Swixit and Turkxit EUDAMED and PRRC information made public Team NB position papers Training – Notified Body situation UK Approv…
 
Subscribe In this episode of the Medical Device made Easy Podcast, I will share with you the progress of the Easy Medical Device project. I hope this will be helping the medical device community and if you need more support, please ask me. I am really here to help you. We will talk about: Podcast Training Consulting Coaching Authorized Representati…
 
Subscribe If you are transitioning from the EU MDD 93/42/EC or 90/385/EEC to the EU MDR 2017/745 or from the IVDD 98/79/EC to the IVDR 2017/745, then you have to be careful with Significant Changes. In this episode, I’ve asked Martin Witte from TÜV SÜD to give us the point of view of Notified Bodies on Significant changes. When we should consider t…
 
Subscribe The registration of Medical Devices is always different and this time we will explain to you how you can do that in Mexico. For that I have invited to the Medical Device made Easy Podcast, Josué Garza from Insumos para la Salud or IPS. Josué will explain to us the pathways needed to register your Medical Devices in Mexico. He will also gi…
 
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