Medical Device made Easy Podcast Archiv
417 Episoden
1 Minute
Medical device news June 2022 is focusing on IVDR 2017/746 date of applciation and consequences. Don't miss all the additional information on guidances, Training,,,
The post Medical Device News: June 2022 Regulatory Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
The post Medical Device News: June 2022 Regulatory Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
We have worked since more than a year on an eQMS called SmartEye and I have invited Anindya Mookerjea the CEO of SCube Technologies to present the tool and talk about the advantages of electronic Quality Management Systems.
The post Let’s introduce you to our eQMS SmartEye with Anindya Mookerjea appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
The post Let’s introduce you to our eQMS SmartEye with Anindya Mookerjea appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
![What to learn about the EU Medical Device situation? [Erik Vollebregt]](https://cdn.podcastcms.de/images/shows/175/983314/s/665083709/what-to-learn-about-the-eu-medical-device-situation-erik-vollebregt.png)
1 Minute
Medtech Forum was really a great event with all the Medical Device stakeholders at the same place. Manufacturers, Consultants, Notified Body, European Commission, trade associations, service providers. Let's summarize that with Erik Vollebregt.
The post What to learn about the EU Medical Device situation? [Erik Vollebregt] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
The post What to learn about the EU Medical Device situation? [Erik Vollebregt] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
The IVDR 2017/746 will go live and this may be a big problem for a lot of companies. We will talk about that with Colm O'Rourke from Trinzo. The IVDR is changing the game so learn about it.
The post What happens after the IVDR Date of Application with Colm O’Rourke appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
The post What happens after the IVDR Date of Application with Colm O’Rourke appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
Software as a Medical Device is an area that is exploding. So understanding how this is working and what to be done is important. Listen to this episode to have more clarity on your projects for EU and US.
The post How to certify your Software as a Medical Device? (SaMD) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
The post How to certify your Software as a Medical Device? (SaMD) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
In this episode, we will review all the changes related to Quality & Regulatory Affairs for Medical Devices in the month of May 2022.
The post Medical Device News: May 2022 Regulatory Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
The post Medical Device News: May 2022 Regulatory Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
![Training Process – What are the mistakes to avoid? [ISO 13485]](https://cdn.podcastcms.de/images/shows/175/983314/s/665083721/training-process-what-are-the-mistakes-to-avoid-iso-13485.png)
1 Minute
Great episode with Rod and Katie on Training Requirements. A lot of afvices that can help you pass audits and remain compliant
The post Training Process – What are the mistakes to avoid? [ISO 13485] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
The post Training Process – What are the mistakes to avoid? [ISO 13485] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
![How your PMCF is evaluated by your Notified Body? [Matthias Fink]](https://cdn.podcastcms.de/images/shows/175/983314/s/665083724/how-your-pmcf-is-evaluated-by-your-notified-body-matthias-fink.png)
1 Minute
This podcast episode will be instrumental for you as PMCF should be part of your strategy. And Matthias Fink from TÜV SÜD will provide you with great advice on how to overcome this task.
The post How your PMCF is evaluated by your Notified Body? [Matthias Fink] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
The post How your PMCF is evaluated by your Notified Body? [Matthias Fink] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
Have you ever performed an audit with a Front Room and Back Room? In this episode I will explain to you how this works and what is the interest. This method can help you to have a smooth audit and make your auditor happy.
The post How to prepare an Audit with a Front Room & a Back Room? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
The post How to prepare an Audit with a Front Room & a Back Room? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
The latest news for the Medical Device Community is on the Medical Device News Podcast. We'll talk about EU, US, MEA, Asia, Notified Bodies, Events, Podcasts. So enjoy!
The post Medical Device News: April 2022 Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
The post Medical Device News: April 2022 Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
![What are the surprises during MDR & IVDR transition? [Erik Vollebregt]](https://cdn.podcastcms.de/images/shows/175/983314/s/665083733/what-are-the-surprises-during-mdr-ivdr-transition-erik-vollebregt.png)
1 Minute
We update you on the situation regarding the MDR and IVDR transition period. Erik Vollebregt will try to provide an explanation why the EMA will now take the control of the Expert Panel for Medical Devices and also why the proposal for a 2 years or more additional transition will be needed.
The post What are the surprises during MDR & IVDR transition? [Erik Vollebregt] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
The post What are the surprises during MDR & IVDR transition? [Erik Vollebregt] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
If you are selling medical devices online or if you plan to sell some, then this episode is for you. This will help you to understand the struggle that you may have or will encounter. Michael Wetherington and I will provide you the keys to be successful in that field.
The post How to sell Medical Devices online in the EU and US? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
The post How to sell Medical Devices online in the EU and US? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
![What lesson did we learn doing Clinical Evaluations? [Cesare Magri]](https://cdn.podcastcms.de/images/shows/175/983314/s/665083739/what-lesson-did-we-learn-doing-clinical-evaluations-cesare-magri.png)
1 Minute
If you are not sure of your Clinical Evaluation, then maybe by listening that you will have a better understanding of what is expected from you. So don't miss the lesson learned with Cesare Magri
The post What lesson did we learn doing Clinical Evaluations? [Cesare Magri] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
The post What lesson did we learn doing Clinical Evaluations? [Cesare Magri] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
You will hear more and more about IVDR and now we talk of the Draft Common Specification. Have a look at the explanation from Andreas that will help you be more efficient if your products are on scope.
The post Why do we need the Common Specification for Class D IVDR? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
The post Why do we need the Common Specification for Class D IVDR? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
This month the big news is about FDA amending QSR to integrate ISO 13485. Not sure on how this will be at the end but it's always cool to have harmonization. No worries, other topics like IVDR, MDCG, UK, Saudi Arabia, Spain are mentioned. Enjoy!!!
The post Medical Device News – March 2022 Regulatory Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
The post Medical Device News – March 2022 Regulatory Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
