Swixit or not Swixit? this is the question with Ronald Boumans
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...
10 Helmi 20200s
Medical Device School – Process Validation or Verification?
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 V...
5 Helmi 20200s
Episode 61 – Medical Device Regulatory Update: January 2020
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 2...
3 Helmi 20200s
How to register your Device in Brazil with Tania Aprigliano? (ANVISA)
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 Apr...
27 Tammi 20200s
Why is it Awesome to work in a Quality or Regulatory affairs job?
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 s...
22 Tammi 20200s
How to create a QMS compliant to MDR with Stefan Bolleininger
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...
20 Tammi 20200s
How to register your Medical Device through 510k with Michelle Lott
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 M...
13 Tammi 20200s
Medical Device School: How to audit your Suppliers?
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 y...
8 Tammi 20200s
