Medical Device made Easy Podcast Archiv
417 Episoden
1 Minute
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 post Class I Medical Devices under MDR with Erik Vollebregt (PART 2) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
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
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
1 Minute
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
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
1 Minute
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
The post Responsibility of a Distributor in MDR & IVDR with Nicolaj Nitzsch appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
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
The post Medical Device School: Product Development or Documentation creation? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
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
The post EUDAMED is delayed, so What? with Richard Houlihan appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
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
The post Literature Search for your CER with Ed Drower appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
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
The post Medical Device School: How to build a Gap Assessment Tool? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
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
The post How to validate an eQMS with Jacob Sjorslev appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
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
The post How to implement an eQMS with Jacob Sjorslev appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
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
The post Medical Device School – Most important issues on your CAPA (ISO 13485) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
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
The post Medical Device Disruptions at Hospitals with Stefan Krojer appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
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
The post 5 FDA Myths for Start-Ups with Justin Bushko appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
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
The post GDPR & MDR for Medical Applications with Jovan Stevovic appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
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
The post Register your Medical Device in the US with Michelle Lott (FDA) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
