Medical Device made Easy Podcast

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