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...
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 benafqir...
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 Device made Easy Podcast . hamza benafqir...
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 practice? appeared first on Medical Device made Easy Podcast . hamza benafqir...
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 Podcast . hamza benafqir...
Did you had this blank in your head when an auditor asked you the validation documents of your software? I know your pain. So today we will try to help you validate your software with some automation. For that I have invited Christophe Girardey from Wega to help move on that direction The post Why you should automate your Software validation? appeared first on Medical Device made Easy Podcast . hamza benafqir...
We feel your pain when your bosses ask you to hire a QA RA person, but the challenge is that there is no Budget for it. But you want to impress them, so what to do. In this episode Mitch Robbins a professional recruiter is telling you what to do. But don’t think this will be easy. The post Hire your QA RA person with no Budget appeared first on Medical Device made Easy Podcast . hamza benafqir...
Everyone is talking about Risk Management file and ask you to provide that to them. But should you do that alone or identify the best partners on your team to be successful. This is what Naveen Agarwal from Creative Analytics Solutions LLC is sharing with us today. The post Who should be on your Risk Management Dream Team? appeared first on Medical Device made Easy Podcast . hamza benafqir...
There is still this misunderstanding about AI, and we wanted to discuss about AI for Medical Devices to really understand what this is. I have invited Christophe Girardey from Wega to put some light in the dark. The post Artificial Intelligence in the Medical Device Industry appeared first on Medical Device made Easy Podcast . hamza benafqir...
Software validation when used on patient is common and mandatory. But now when we tell you that you should validate also the software you are using to record your documents, CAPAs, or work on the elements related to the product, then this start to be a bit tricky. Medical Device companies are not used to such requirements and we will explain how they should proceed on this podcast. The post Validation of Quality Software in Medical Devices appeared first on Medical Device made Easy Podcast . ham...
Saudi Arabia is a major actor in the Medical Device world. A lot of companies are willing to enter this market that can help them to reach also other regions of the Middle East. We will discuss with Ahmed Hendawy from Registitute about the way to register your medical devices with SFDA authorities. The post How to register Medical Devices in Saudi Arabia? appeared first on Medical Device made Easy Podcast . hamza benafqir...
july 2023regulatory update The post Medical Device News – July 2023 Regulatory Update appeared first on Medical Device made Easy Podcast . hamza benafqir
UK decided to add more time to implement the UKCA. Apparently, the EU amendment to extend the EU MDR and IVDR was also something they looked at to define their timeline. So, let’s see what will this mean for manufacturers with Alex Denoon, partner at the law firm Bristows. The post What should you know on UKCA extension appeared first on Medical Device made Easy Podcast . hamza benafqir...
You may be on the business of Software development and you ask yourself why your Dev team is not really happy to work with Quality and Regulatory affairs team? In this episode, we will discuss with Christophe Girardey from WEGA about the gaps and how this can be solved. The post How to connect Software dev and QA RA Team appeared first on Medical Device made Easy Podcast . hamza benafqir...
