On this episode, Naveen Agarwal will explain to us the consequences for the alignment between QMSR and ISO 13485.
The post Learn more about FDA QMSR alignment with ISO 13485 appeared first on Medical Device made Easy Podcast. hamza benafqir
EU Training Services ROW USA CANADA Mexico Saudi Arabia Qatar Australia PODCAST EASY MEDICAL DEVICE Services:
The post Medical Device News March 2024 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir
The recent Proposal on Medical Device shortage, EUDAMED Timeline and IVDR transition is discussed and the question is will this become law. The other question is, Do we think this will change something to the Medical Device situation?
The post New EU Proposal – EUDAMED, IVDR & Shortage appeared first on Medical Device made Easy Podcast. hamza benafqir
EtO is one the widest methodology used to sterilize medical devices. So what is the consequence if the EtO gaz is now considered as a Medical Device?
The post Will EtO gaz become a Medical Device? appeared first on Medical Device made Easy Podcast. hamza benafqir
The preparation for your interview is important this is why I have invited Elena Kyria from Elemed to help us.
The post How to get your interview prepared? appeared first on Medical Device made Easy Podcast. hamza benafqir
This month we'll talk about the updates in EU and the rest of the world. The IVDR extension, the MDCG guidances, the language requirements, the trainings, events, podcast... ALL ALL ALL. Check that now.
The post Medical Device News february 2024 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir
In this episode, Saad will be explaining to us what Q-Sub or Pre-Submission by the FDA is. And why this may be your Superpower before you submit to the FDA. So don’t miss this if you plan an FDA application soon.
The post Why you should use Pre-Submission or Q-Sub with FDA? appeared first on Medical Device made Easy Podcast. hamza benafqir
You are not manufacturing the product you are selling. Can you be EU MDR certified?
The post You are not the Physical Manufacturer, can you be MDR certified? appeared first on Medical Device made Easy Podcast. hamza benafqir
Medica 2023 was really a great event and I am please to provide you here with a summary and interviews with multiple actors. You’ll see that this is so diverse. […]
The post MEDICA 2023 – InterviewS with Startups, Service Providers, Notified Bodies… appeared first on Medical Device made Easy Podcast. hamza benafqir
The extension of the EU MDR and IVDR created some misunderstanding and in this episode, I invited Pritam from TÜV SÜD to help us understand when to apply to a Notified Body, the cost of it, the expectation in terms of timing. So don't miss it
The post WARNING! APPLY TO YOUR NOTIFIED BODY NOW! appeared first on Medical Device made Easy Podcast. hamza benafqir
Medboard Who is Medboard EU EU Reference laboratories EURL Letter to EU Parliament Letter sent to the European Parliament – Cybersecurity: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CONSIL:ST_17000_2023_INIT MDCG 2023-7 on Clinical Investigation MDCG 2019-07 rev […]
The post Medical Device News – january 2024 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir
A Heatmap is a visual representation of data where values in a matrix are represented as colours. Let’s review with Stefan Bolleininger how this may help Regulatory Affairs departments.
The post Regulatory Maturity Model – Heatmap (MEDICA 2023) appeared first on Medical Device made Easy Podcast. hamza benafqir
Easy Medical Device has its podcast and many other Quality and Regulatory Affairs people are also doing podcasting. I have met with Claudia and Jorg who are also having a podcast and we reviewed our experience and encouraged people to also start their podcast. Check our experience and learn from it.
The post Life of QA RA Podcasters? appeared first on Medical Device made Easy Podcast. hamza benafqir
To be able to sell products in different countries, you need to understand what are the requirements for each of them. This is where the Regulatory Affairs department is helping. In this episode we will explain to you why this is important to consider them as an asset and also how they can be more productive.
The post Why should you invest in your Regulatory Team? appeared first on Medical Device made Easy Podcast. hamza benafqir
The usability is a term that seems complicated but within this episode Michael Engler we will try to explain to you in simple terms how you can succeed within your project. So don’t miss this episode
The post What is Usability for Medical Devices? appeared first on Medical Device made Easy Podcast. hamza benafqir
This is the last Medical Device News of 2023 so I hope this will contain all information needed. Enjoy your Regulatory Update!
The post Medical Device News: December 2023 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir
During the MEDXD in Berlin, we had a panel discussion on digitalization. Monir El Azzouzi was moderating it with some expert in Medical Device digitalization topics.
The post What is the situation regarding digitalization in Medtech? appeared first on Medical Device made Easy Podcast. hamza benafqir
In this episode, Beat Keller from imt will be helping us to understand the secrets of Predicate Devices. This is specific to the US Market, but we will also make few parallels with the EU as we have also the possibility to use equivalent device within the EU MDR. But is it the same?
The post How to find your Predicate Device for your 510K Submission? appeared first on Medical Device made Easy Podcast. hamza benafqir
In this episode, Cesare Magri will help us understand how API can be considered as a Medical Device. Some calculators are existing and also used as API. So should those API developers create a QMS and Technical File for their product? How can you prove your API is safe and performant? Check answers on this episode
The post How to CE certify a Calculator, Risk Score…? appeared first on Medical Device made Easy Podcast. hamza benafqir
This episode will be your Update of what happened within the Medical Device community. Check the show notes for all the links. Use these updates also for your QMS Regulatory updates so don’t hesitate to make your own assessment.
The post Medical Device News – November 2023 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir
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