Medical Device made Easy Podcast Archiv
417 Episoden
1 Minute
In this episode, Claire Dyson will give us the recipe to launch correctly your Medical Device when you go abroad and for that we will take the example of EU and US.
The post UK vs EU vs US – How to switch to another region easily? appeared first on Medical Device made Easy Podcast. hamza benafqir
The post UK vs EU vs US – How to switch to another region easily? appeared first on Medical Device made Easy Podcast. hamza benafqir
1 Minute
In this episode, Cesare Magri will try to improve our skills on PMCF literature search. We will investigate on the misconceptions and what people should make to do it right.
The post How to do a PMCF Literature Search for Medical Devices? appeared first on Medical Device made Easy Podcast. hamza benafqir
The post How to do a PMCF Literature Search for Medical Devices? appeared first on Medical Device made Easy Podcast. hamza benafqir
1 Minute
EU Switzerland Training Events: ROW Medical Device Live Expert: Podcast
The post Medical Device News, Septembre 2024 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir
The post Medical Device News, Septembre 2024 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir
1 Minute
n this episode, Martin King will share with us his practice of AI in the context of Quality and Regulatory affairs for medical devices. This will explain to you some best practices to maintain to avoid some pitfalls.
The post How to use AI GPT for your Quality and Regulatory work? appeared first on Medical Device made Easy Podcast. hamza benafqir
The post How to use AI GPT for your Quality and Regulatory work? appeared first on Medical Device made Easy Podcast. hamza benafqir
1 Minute
In this episode, Stephen O’Rourke that was not working within the Medical Device industry will share with us is journey from Zero knowledge in the field to running projects. Listen to his journey in case you are also willing to breakthrough the medical device field.
The post How to go from Zero to Hero in Medical Devices? appeared first on Medical Device made Easy Podcast. hamza benafqir
The post How to go from Zero to Hero in Medical Devices? appeared first on Medical Device made Easy Podcast. hamza benafqir
1 Minute
: In this episode, I have invited Ralf Gansel to help us understand the process for Certification of your product and what is the lifecycle for it. We’ll discuss about Transfer or certificates, or notification of changes or why there is a renewal and not continuous surveillance…
The post Manage the Transfer/Renewal/Surveillance/Change of your CE certificate appeared first on Medical Device made Easy Podcast. hamza benafqir
The post Manage the Transfer/Renewal/Surveillance/Change of your CE certificate appeared first on Medical Device made Easy Podcast. hamza benafqir
1 Minute
In this episode, Beat Keller will help you understand Harmonized Standards and how to use them and also how to do when there is no Harmonized Standards. So stay tuned.
The post How to use Harmonized Standards for Medical Devices? appeared first on Medical Device made Easy Podcast. hamza benafqir
The post How to use Harmonized Standards for Medical Devices? appeared first on Medical Device made Easy Podcast. hamza benafqir
1 Minute
TÜV SÜD is one of the main notified bodies. And they are celebrating their 100th Class D certificate. Andreas Stange will explain to us what they learned and how manufacturers can improve their certification process.
The post IVDR Class D – Lesson learned from Notified Bodies appeared first on Medical Device made Easy Podcast. hamza benafqir
The post IVDR Class D – Lesson learned from Notified Bodies appeared first on Medical Device made Easy Podcast. hamza benafqir
1 Minute
The EU MDR is in constant update and this change on the interruption of supply of medical devices should be integrated.
The post EU MDR Major update: Interruption or Discontinuation of supply! appeared first on Medical Device made Easy Podcast. hamza benafqir
The post EU MDR Major update: Interruption or Discontinuation of supply! appeared first on Medical Device made Easy Podcast. hamza benafqir
1 Minute
How to register your Medical Devices in the UAE with Ahmed Hendawy from Registitute and Monir El Azzouzi from Easy Medical Device
The post How to register your Medical Device in the UAE? appeared first on Medical Device made Easy Podcast. hamza benafqir
The post How to register your Medical Device in the UAE? appeared first on Medical Device made Easy Podcast. hamza benafqir
1 Minute
Medical Devices should follow regulations like EU MDR or IVDR but also some regulations that are also targeting some components like batteries. So for that there is EU Battery Regulation 2023/1542. Erik Vollebregt from Axon Lawyers will explain the impact of the regulation to your product.
The post EU Battery Regulation – How to be ready? appeared first on Medical Device made Easy Podcast. hamza benafqir
The post EU Battery Regulation – How to be ready? appeared first on Medical Device made Easy Podcast. hamza benafqir
1 Minute
The AI Act will be soon officially published even if we know the text will not change. So let’s help you to be prepared for its implementation. Fabien Roy will explain the challenges that he has recognized.
The post AI Act – What are the challenges for Medical Devices? appeared first on Medical Device made Easy Podcast. hamza benafqir
The post AI Act – What are the challenges for Medical Devices? appeared first on Medical Device made Easy Podcast. hamza benafqir
1 Minute
Medboard EU UK Swiss MEDTECH CONF LIVE SESSION US Australia Saudi Arabia Malaysia South Africa PODCAST Social Media to follow
The post Medical Device News, July 2024 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir
The post Medical Device News, July 2024 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir
1 Minute
As a Software developer, we need to understand what a Regulator can look at when you submit an AI/ML Model. Let’s listen to Richie Christian from Wega
The post How to submit your AI/ML SAMD the right way? appeared first on Medical Device made Easy Podcast. hamza benafqir
The post How to submit your AI/ML SAMD the right way? appeared first on Medical Device made Easy Podcast. hamza benafqir
1 Minute
The Notified Body is an important actor for Medical Devices that seek a CE certification under EU MDR and IVDR. In this Episode Thomas Lommatzsch from AFNOR will explain to us the difficult process of designation.
The post AFNOR – How is a Notified Body designated? appeared first on Medical Device made Easy Podcast. hamza benafqir
The post AFNOR – How is a Notified Body designated? appeared first on Medical Device made Easy Podcast. hamza benafqir
