Medical Device made Easy Podcast Archiv
417 Episoden
1 Minute
Many medical device manufacturers try to solve a puzzle regarding their Low risk medical devices. How to write Clinical Evaluation for it without data? here is the solution. Download the presentation.
The post Clinical Data for Low Risk Medical Devices with Robert van Boxtel appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
The post Clinical Data for Low Risk Medical Devices with Robert van Boxtel appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
In this episode we will explain you the way that Economic Operators are controlled. This may seem obvious but the answer can be different per Economic Operator. So listen to this short episode of Medical Device School to understand everything.
The post Medical Device School – Who controls your Economic Operators? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
The post Medical Device School – Who controls your Economic Operators? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
Brexit, Swixit, Turkxit. These are the topics of this episode of the Podcast. We will try to help you understand all these -XIT and what is the impact to Medical Device manufacturers.
The post Are Brexit, Swixit, and Turkxit a reality? with Erik Vollebregt appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
The post Are Brexit, Swixit, and Turkxit a reality? with Erik Vollebregt appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
Who are the Economic Operators mentioned on the MDR and IVDR? This is the question that Monir El Azzouzi and Erik Vollebregt will try to answer.
The post Medical Device School – Who are your Economic Operators? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
The post Medical Device School – Who are your Economic Operators? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
Swixit or not Swixit? is an alert to Medical Device Manufacturers regarding the political game that is played between Europe and Switzerland. Let's see the impact for the Swiss market but also for the EU market.
The post Swixit or not Swixit? this is the question with Ronald Boumans appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
The post Swixit or not Swixit? this is the question with Ronald Boumans appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
Process Validation or Verification? Some people are mixing both concepts, this is why Monir and Stefan will help you understand when to use one or the other.
The post Medical Device School – Process Validation or Verification? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
The post Medical Device School – Process Validation or Verification? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
This episode will be dedicated to provide the regulatory updates that happened on January 2020. This will help you to stay up-to-date.
The post Episode 61 – Medical Device Regulatory Update: January 2020 appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
The post Episode 61 – Medical Device Regulatory Update: January 2020 appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
As Tania is saying this is the best time to export your products to Brazil, so we'll teach you how to register your products there. Enjoy!
The post How to register your Device in Brazil with Tania Aprigliano? (ANVISA) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
The post How to register your Device in Brazil with Tania Aprigliano? (ANVISA) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
Quality and Regulatory affairs is not really a job that everyone want to work in. But this is maybe you didn't listen to the right arguments. Check what Monir El Azzouzi and Karandeep Badwal want to say.
The post Why is it Awesome to work in a Quality or Regulatory affairs job? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
The post Why is it Awesome to work in a Quality or Regulatory affairs job? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
MDR is requiring to create a Quality Management System but how to do that. This is what you will learn with Monir El Azzouzi and Stefan Bolleininger.
The post How to create a QMS compliant to MDR with Stefan Bolleininger appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
The post How to create a QMS compliant to MDR with Stefan Bolleininger appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
Michelle Lott is my guest and will help us understand the 510k registration process with the US FDA. Should you use it? Is this changing? Learn everything in 1 episode.
The post How to register your Medical Device through 510k with Michelle Lott appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
The post How to register your Medical Device through 510k with Michelle Lott appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
How should you audit your suppliers? Should you do the same as a Notified Body? Monir El Azzouzi and Stefan Bolleininger are providing you their opinion.
The post Medical Device School: How to audit your Suppliers? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
The post Medical Device School: How to audit your Suppliers? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
PMCF is a key element of the Post-Marketing Surveillance process. As there were a lot of questions about it then I decided to ask Helene Quie some questions while I was at Medica 2019.
The post Post-Marketing Clinical Follow-up with Helene Quie (PMCF) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
The post Post-Marketing Clinical Follow-up with Helene Quie (PMCF) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
This is the last episode of 2019 and I wanted to summaries the situation and introduce you to my 2020 projects.
The post I wish you a Happy New Year 2020 with Monir El Azzouzi appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
The post I wish you a Happy New Year 2020 with Monir El Azzouzi appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
With the MDR, more and more clinical data are needed. But how will you collect them. David Rutledge will show you 6 ways to collect those data and the pros and cons for each of them.
The post 6 ways to collect Clinical Data with David Rutledge appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
The post 6 ways to collect Clinical Data with David Rutledge appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
