Medical Device made Easy Podcast
297 episodes - English - Latest episode: 7 days ago - ★★★★★ - 17 ratingsListen Medical Device Regulation and Standards
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Episodes
How to interpret the first Expert Panel Opinion? [Bassil Akra]
July 13, 2021 00:00Bassil 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
Medical Device News: The July 2021 Update [MDR IVDR FDA SFDA]
July 06, 2021 00:00We 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
How to build your State-of-the-art for your Medical Devices?
June 29, 2021 00:00The 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
How Intellectual Property is linked to the Medical Device Regulation?
June 22, 2021 00:00In 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
How to perform a good Clinical Investigation with Helene Quie
June 15, 2021 00:00Clinical 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
How to perform a Biological Evaluation for your Medical Device?
June 08, 2021 00:00This 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 [EU MDR Date of Application]
June 01, 2021 00:00Medical 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 Survey: What is the Industry’s opinion? [Catherine Higginson]
May 25, 2021 00:00EU 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
MDR is coming so brace yourself with Erik Vollebregt
May 18, 2021 00:001 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
FDA: Is the Emergency Use Authorization worth it? (EUA)
May 11, 2021 01:00This 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
Medical Device News – May 2021 Update [EU MDR 2017/745]
May 04, 2021 00:00This 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
Checklist – What is important before the EU MDR Date of Application?
April 27, 2021 00:00It 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
How to perform correctly a Merger & Acquisition during the MDR transition?
April 20, 2021 00:00Merger 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
How to write your Performance Evaluation? [IVDR 2017/746]
April 13, 2021 00:00In this episode Hakan Inan will help us to write our Performance Evaluation specifically for IVD products. The post How to write your Performance Evaluation? [IVDR 2017/746] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Medical Device News – April 2021 Update [EU MDR & IVDR]
April 06, 2021 00:00In this episode, we will summaries what happened for the Medical Device Community. We will explain to you the last MDCG Guidances that were issued and the Notified Bodiy Situation. The post Medical Device News – April 2021 Update [EU MDR & IVDR] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Will it be really difficult for IVD manufacturers? [IVDR 2017/746]
March 30, 2021 00:00IVDR 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
How to create a Label under MDR? (Questions & Answers)
March 23, 2021 00:00During 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
How System and Procedure Pack are regulated under EU MDR?
March 16, 2021 00:00The 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
How to import your Medical Devices with an Independent Importer?
March 09, 2021 00:00In 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
What is the Medical Device News? [March 2021 update]
March 02, 2021 00:00In 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
The best design methods for successful development? [Jon Speer]
February 23, 2021 00:00Waterfall 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 QA RA job for Medical Devices? [Karandeep Badwal]
February 16, 2021 00:00How 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
What is the QA RA Mindset with Michelle Lott
February 09, 2021 00:00If 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
February 2021 Update – Medical Devices Remote Audit by the EU
February 02, 2021 00:00On 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
How to perform your PMS more easily with Ivan Perez Chamorro?
January 26, 2021 00:00PMS 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
How to get the MDR certification for Artificial Intelligence Softwares?
January 19, 2021 00:00The 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
How to register a Medical Device in Israel? (Liat Nadel)
January 12, 2021 00:00Liat 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
Medical Device News – January 2021 Update (Monir El Azzouzi)
January 05, 2021 09:00In 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
How Easy Medical Device can help you? (Monir El Azzouzi)
December 28, 2020 00:00This 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
How to deal with Significant Changes within MDR & IVDR with Martin Witte
December 21, 2020 00:00Martin 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
How to register a Medical Device in Mexico? [Josué Garza]
December 14, 2020 00:00You 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
Medical Device News: What happened in November 2020?
December 07, 2020 00:00This 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
Is it Easy for a Notified Body to get EU MDR accredited?
November 30, 2020 00:00In 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
How a Quality & Regulatory training can help you? [Sofmedica]
November 23, 2020 00:00In 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
Do you need an Expert Panel for your Medical Devices? [Bassil Akra]
November 16, 2020 00:00If 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
What are Common Specifications under EU MDR & IVDR?
November 09, 2020 00:00Common 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
We’ve reached episode 100 – What happened for the last 2 years?
November 02, 2020 00:00We have reached 100 episodes on the podcast and today we will celebrate that. Here is an episode with some of the great influencers in the Medical Device field which are sharing with us their journey. What happened to you since the last years. The post We’ve reached episode 100 – What happened for the last 2 years? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
How to certify a self-testing device under IVDR? [Erik Vollebregt]
October 26, 2020 00:00Self-testing devices are already existing in the market and already mentioned under IVDD. But what does change with the new IVDR? Erik Vollebregt from Axon Lawyers will help us to interpret that. The post How to certify a self-testing device under IVDR? [Erik Vollebregt] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
What is the cost of EU MDR 2017/745? [Catherine Higginson]
October 19, 2020 00:00EU MDR is a new regulation and if you have not started a project like that you need to understand that it is costing. Not only money but time, resource... So listen to this episode if you want to understand what you can expect from this type of projects. The post What is the cost of EU MDR 2017/745? [Catherine Higginson] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
How to register your Medical Device in the ASEAN region?
October 12, 2020 00:00Michael Wetherington will by your instructor in this episode. He will provide you all the information to register your product in the ASEAN region. This is the countries located in the South East Asia. The post How to register your Medical Device in the ASEAN region? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
The latest news on Brexit, Swixit and EU MDR [Medical Device News]
October 05, 2020 00:00This month a lot of exists on the Medical Device news. We are still under a pandemic so conferences are going virtual and Easy Medical Devices has the best training for EU MDR. The post The latest news on Brexit, Swixit and EU MDR [Medical Device News] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
How to register ATMP-Device combination products?
September 28, 2020 00:00ATMP is a category of product not so well known by the regulatory affairs professionals. I wanted to help you understand how they are working with Margareth Jorvid. She will provide us with a specific overview for ATMP-Device combination products. The post How to register ATMP-Device combination products? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
How to get some help from Medical Device Regulators with Cliff Bleustein
September 21, 2020 00:00In this case study we will see how Apos Therapy was able to register his product in the US for certain therapy. Cliff Bleustein; President and CEO of Apos Therapy is my guest today and you'll see that for a CEO he knows a lot about regulatory affairs. The post How to get some help from Medical Device Regulators with Cliff Bleustein appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
How can GDPR impact Medical Devices with Erik Vollebregt
September 14, 2020 00:00GDPR is not specific to medical devices, but any judgment that is issued can impact devices. And this is the case with the SHREMS II case. Erik Vollebregt accepted to answer my questions on this technical topic to help us understand how to remain compliant. The post How can GDPR impact Medical Devices with Erik Vollebregt appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Be successful at your MDR and IVDR audit with Martin Witte
September 07, 2020 00:00The audit for a Medical Device company can be a real struggle if this was not correctly prepared. If you want to understand what a Notified Body is looking for when it is coming to your company, then you should listen to Martin Witte from TÜV SÜD. Who better than a Notified Body to tell you what a Notified Body wants to see. The post Be successful at your MDR and IVDR audit with Martin Witte appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Medical Device News – August 2020 Review (Monir El Azzouzi)
August 31, 2020 00:00In this episode we will talk about the UDI FAQ, the new regulation for reprocessing of single use devices, the EUDAMED actor module, the new Guidances released... A lot to discuss today. The post Medical Device News – August 2020 Review (Monir El Azzouzi) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
How to switch quickly to a Virtual Conference with TOPRA
August 24, 2020 00:00Kevin Pay and Raluca Radu from TOPRA are helping us to understand how a virtual conference can bring the same type of experience as a normal one. This year the TOPRA Symposium will be virtual so you can assist to it without to travel. Let's listen how this will be organized, The post How to switch quickly to a Virtual Conference with TOPRA appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Best practice for Device Testing with Michael Wetherington
August 17, 2020 00:00Medical Device Testing is something all medical device manufacturers should perform. How can you prove that your device is safe and performing without that. So now how to do it? Michael Wetherington from Medical Regs will be my guest on this episode of the podcast. He will share with us all best practices. The post Best practice for Device Testing with Michael Wetherington appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Best overview of IEC 60601 for Medical Device electrical equipment
August 10, 2020 00:00IEC 60601 is one of the most important standard to look at if you have an electrical medical devices. In this episode Leonard Eisner also called the IEC 60601 guy will help us understand the full situation. So be ready to learn a lot today. The post Best overview of IEC 60601 for Medical Device electrical equipment appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Medical Device News – July 2020 Update on Quality and Regulatory for Medical Devices
August 03, 2020 00:00In this monthly update we will review some hot topics that happened within the last weeks., the Notified Body Situation, the Guidance and standards update and finally what happened at Easy Medical Device. The post Medical Device News – July 2020 Update on Quality and Regulatory for Medical Devices appeared first on Medical Device made Easy Podcast. Monir El Azzouzi