Medical Device made Easy Podcast

In this episode, Amandine Broussier will share with us her expertise on Usability with a specific scope on the summative evaluation. The objective will be to share with you some of the common mistakes done by the industry. The post Summative Evaluation – Common mistakes appeared first on Medical Device made Easy Podcast. hamza benafqir

Sometimes, you want to manufacture a product, but you don’t have the capacity or even the infrastructure. Then why not asking a Contract Manufacturer to do that for you. Let’s explain to you that you should take care of when working with one. The post Are you more Corrections or Corrective Actions or Preventive Actions? appeared first on Medical Device made Easy Podcast. hamza benafqir

Sometimes, you want to manufacture a product but you don’t have the capacity or even the infrastructure. Then why not asking a Contract Manufacturer to do that for you. Let’s explain to you what you should take care of when working with one. The post How to select and evaluate your Contract Manufacturer? appeared first on Medical Device made Easy Podcast. hamza benafqir

Some of you may think that Field Service has nothing to do with Quality or Regulatory Affairs, but after this episode you may see some links and you may understand how this is working. Listen to Michael Israel on how to perform Field Service. The post Quality Field Service for Medical Devices appeared first on Medical Device made Easy Podcast. hamza benafqir

EU Article to read Training Events Rest of the world Mexico: Draft Mexican official standard –Labelling of Medical Devices: https://www.dof.gob.mx/nota_detalle.php?codigo=5724246&fecha=23/04/2024#gsc.tab=0 Podcast The post Medical Device NewsMAY 2024 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir

You may think that this is a nice to have but after listening to that you’ll have the arguments to convince your company to build it. Check this episode with Lesley Worthington and start the creation of a Quality Culture that will shape your company for many years. The post Why and how to build a Quality Culture? appeared first on Medical Device made Easy Podcast. hamza benafqir

We talked a lot about the AI ACT and now it becomes reality. This is or will be live soon. But what are the consequences for Medical Device manufacturers who are using Artificial Intelligence for their devices? Lets review that with Erik Vollebregt The post What is the impact of AI Act on Medical Devices? appeared first on Medical Device made Easy Podcast. hamza benafqir

Adam will inform us about the documentation needed for building your Sterilisation master file specifically for radiation sterilization. Check this out. The post Radiation Sterilisation Master File (ISO 11137 & 11607) appeared first on Medical Device made Easy Podcast. hamza benafqir

Sponsor: Medboard: https://www.medboard.com/ EU UK Ireland Turkey Events Services ROW USA Australia Saudi Arabia Brazil India Malaysia China Podcast Easy Medical Device Social Media to follow The post Medical Device News April 2024 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir

On this episode, Steve Curran from Trinzo will help us understand how to be better at doing your Postmarketing Surveillance. The post How to benefit from Surveys to build Clinical Evidence? appeared first on Medical Device made Easy Podcast. hamza benafqir

On this episode, Steve Curran from Trinzo will help us understand how to be better at doing your Postmarketing Surveillance. The post How to do Postmarketing Surveillance the right way? appeared first on Medical Device made Easy Podcast. hamza benafqir

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

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. hamza benafqir

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