Medical Device made Easy Podcast Archiv
417 Episoden
![How to register a Medical Device in Mexico? [Josué Garza]](https://cdn.podcastcms.de/images/shows/175/983314/s/665083923/how-to-register-a-medical-device-in-mexico-josue-garza.png)
1 Minute
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
The post How to register a Medical Device in Mexico? [Josué Garza] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
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
The post Medical Device News: What happened in November 2020? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
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
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]](https://cdn.podcastcms.de/images/shows/175/983314/s/665083932/how-a-quality-regulatory-training-can-help-you-sofmedica.png)
1 Minute
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
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]](https://cdn.podcastcms.de/images/shows/175/983314/s/665083934/do-you-need-an-expert-panel-for-your-medical-devices-bassil-akra.png)
1 Minute
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
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
1 Minute
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
The post What are Common Specifications under EU MDR & IVDR? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
We 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
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]](https://cdn.podcastcms.de/images/shows/175/983314/s/665083944/how-to-certify-a-self-testing-device-under-ivdr-erik-vollebregt.png)
1 Minute
Self-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
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]](https://cdn.podcastcms.de/images/shows/175/983314/s/665083946/what-is-the-cost-of-eu-mdr-2017745-catherine-higginson.png)
1 Minute
EU 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
The post What is the cost of EU MDR 2017/745? [Catherine Higginson] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
Michael 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 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]](https://cdn.podcastcms.de/images/shows/175/983314/s/665083952/the-latest-news-on-brexit-swixit-and-eu-mdr-medical-device-news.png)
1 Minute
This 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
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
1 Minute
ATMP 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
The post How to register ATMP-Device combination products? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
In 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
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
1 Minute
GDPR 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
The post How can GDPR impact Medical Devices with Erik Vollebregt appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
The 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
The post Be successful at your MDR and IVDR audit with Martin Witte appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
