Medical Device made Easy Podcast

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 m...

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 bena...

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...

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 Podc...

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 Dev...

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

MDCG 2023-4 was released and this raised a lot of questions or concerns. If you are using a software and for the functioning of it you need sensors or cameras from a third party device like a smartphone, then who is responsible to validate this third party device? The post Validate your Iphone, Samsung Galaxy, Huawei… for your Software appeared first on Medical Device made Easy Podcast . hamza ben...

This is part 2 of the interviews made at Afrisummit. I was able to interview some key stakeholders. I am sharing with you these interviews and I hope this will help you understand the situation in Middle East and Africa. The post Afrisummit 2023 Interviews Part 2 – Egypt Situation  appeared first on Medical Device made Easy Podcast . hamza benafqir

When I was at the Afrisummit I was able to interview some key stakeholders. I am sharing with you these interviews and I hope this will help you understand the situation in Middle East and Africa. The post Afrisummit 2023 Interviews Part 1 appeared first on Medical Device made Easy Podcast . hamza benafqir

When we develop a Software, there are some pitfalls that you can avoid. Weronika Michaluk from HTD Health will explain to us how to do that. Don’t miss this to accelerate your development and avoid to redo some activities. The post What are some pitfalls to avoid during Software Design? appeared first on Medical Device made Easy Podcast . hamza benafqir

MEDICAL DEVICE NEWS October 2023 Regulatory Update The post October 2023 Regulatory Update appeared first on Medical Device made Easy Podcast . hamza benafqir

In this episode, Richard Houlihan will explain to us the current situation about EUDAMED. This is the new European Database for Medical Devices and a lot of people are asking to start the registration on EUDAMED. But EUDAMED is not complete for the moment, so should we rush? When will this been mandatory? Let’s review that together. The post What is the EUDAMED Updates? appeared first on Medical D...

In this second part of this podcast series on Team-Prrc interviews. we have 3 additional guests. Don’t miss the first one where we also got great interviews. In this episode, […] The post Interviews on Being The PRRC (Part 2) appeared first on Medical Device made Easy Podcast . hamza benafqir

This month we will review all what happened in the Medical Device world during the last weeks and what will happen in the next weeks. Check that The post MEDICAL DEVICE NEWS – SEPTEMBER 2023 Regulatory Update appeared first on Medical Device made Easy Podcast . hamza benafqir

If your Medical Device needs to be cleaned then it means that you need to prove that the cleaning method you propose is working. So how to do that? A laboratory can help for this by testing your method. But what can be some traps to that? Let’s listen to Enrico Allegra from TestLabs to understand how you can do this action in a safe mode. The post How to perform your Cleaning Validation in practic...

We all want to follow EU MDR 2017/745 but for that you need to have clinical data and a clinical evaluation. But what are the acceptance criteria for it? Who defines the rules? Can this evolve? All these questions will be answered on this podcast with Cesare Magri from 4BetterDevices. The post What are the Acceptance Criteria for your Clinical Evaluation? appeared first on Medical Device made Easy...