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
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...
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
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
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
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...
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
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...
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
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...
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
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...
Before to look at this episode, you should go to Part 1. On this second part we'll continue to discuss Class I up-classified situation and then pure Class I devices under MDR. The post Class I Medical Devices under MDR with Erik Vollebregt (PART 2) appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
The MDR Corrigendum 2 is changing the rules for some class I devices under MDD that are up classified under MDR. Let's see what manufacturers should do. The post Corrigendum 2 – Changes for Class I Devices with Erik Vollebregt (Part 1) appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
If you have a product and you want to evaluate if this is a Medical Device, then you need to follow the 3 steps that we will discuss on this episode. Heikki Pitkänen's platform is providing a solution for your to evaluate your device and he offers it for free to the listeners of this podcast. Thanks to him. The post How to evaluate your Medical Devices in 3 Steps with Heikki Pitkänen? appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
What is the role of a Distributor within the new MDR 2017/745 and IVDR 2017/746. This is the question that I asked my guest who is working as distributor of Medical Devices in Norway. The post Responsibility of a Distributor in MDR & IVDR with Nicolaj Nitzsch appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
When you are trying to create your product there is one question that you should answer: Should you focus on your product development or your documentation creation? Listen to our argument on this episode of the podcast. The post Medical Device School: Product Development or Documentation creation? appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
EUDAMED is delayed but what should do Medical Device manufacturers to continue be compliant. Richard Houlihan is a EUDAMED expert and will help us understand. The post EUDAMED is delayed, so What? with Richard Houlihan appeared first on Medical Device made Easy Podcast . Monir El Azzouzi
When creating your Clinical Evaluation Report or CER, you maybe need to perform a literature search. There is a certain method for that and we wanted to help you to understand it with Ed Drower from CiteMedical Solution The post Literature Search for your CER with Ed Drower appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
In this Bonus episode of Medical Device School we will talk about Gap Assessment tools. You know that when there is a regulation or something that you should put in place, you need to perform a gap assessment. To check where you are and if you are compliant to where you want to be. Let'S see if you follow our discussion with Stefan Bolleininger. The post Medical Device School: How to build a Gap Assessment Tool? appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
After episode 47 on how to implement an eQMS, Jacob Sjorslev is now telling us how to validate an eQMS. This is something mandatory now since ISO 13485:2016. So listen carefully and download the giveaway, The post How to validate an eQMS with Jacob Sjorslev appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
An eQMS can be a necessary tool for your Quality Management System. This is why it's implementation should be executed as a project. Jacob Sjorslev will be your instructor and tell what to do and what to avoid. And Jacob will also make you an offer at the end of the episode. The post How to implement an eQMS with Jacob Sjorslev appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
On the Medical Device School segment, we will help you understand how to be better with your CAPA system. Stefan Bolleininger and Monir El Azzouzi are sharing with you their experience. The post Medical Device School – Most important issues on your CAPA (ISO 13485) appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
Some signs are raising from Hospitals regarding disruptions on Medical Devices. What is exactly the reason. Stefan Krojer will share with us his experience and a solution he is developing. The post Medical Device Disruptions at Hospitals with Stefan Krojer appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
Justin Bushko from Concise Engineering will share with us 5 FDA Myths that exist on the Start-up world. Medical Devices Start-Ups should satisfy Investors and Regulatory, and this can create some strange assumptions. Let'S listen to that. The post 5 FDA Myths for Start-Ups with Justin Bushko appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
GDPR is also important for the MDR regulation. As we are developing Medical Device application, we should also implement GDPR on our development. Jovan Stevovic from Chino.io will help us understand what it means. The post GDPR & MDR for Medical Applications with Jovan Stevovic appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
There are many ways to register a Medical Device in the USA and I propose you to listen to Michelle Lott that will tell you the basics of the FDA regulations. The post Register your Medical Device in the US with Michelle Lott (FDA) appeared first on Medical Device made Easy Podcast . Monir El Azzouzi
In-Vitro Diagnostic Regulation will come later and we have time. Maurizio Suppo do have another opinion and as he is really passionate about this topic he will be providing some golden advice that you should not miss. Even for non-IVD manufacturers as we will talk about a proposal if manufacturers cannot meet the deadline. The post New rules for the In-Vitro Diagnostic Industry with Maurizio Suppo appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
On this episode I invited Natasha Bankowski that is also called the PMS Queen to help us understand the Post Marketing Surveillance for Medical Devices. You can also meet her at TOPRA Symposium 2019. The post Learn Post Market Surveillance with Natasha Bankowski appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
This episode with Helene Quie from Qmed Consulting contains Diamond of Information. If you are lost regarding Product Equivalence for your CER, then you need to listen that and it will be clearer. The post Product Equivalence for Clinical Evaluation Report (CER) with Helene Quie appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
