Latest Meddevice Podcast Episodes
How to submit your AI/ML SAMD the right way?
Medical Device made Easy Podcast - June 25, 2024 00:00 ★★★★★ - 18 ratingsAs a Software developer, we need to understand what a Regulator can look at when you submit an AI/ML Model. Let’s listen to Richie Christian from Wega The post How to submit your AI/ML SAMD the right way? appeared first on Medical Device made Easy Podcast. hamza benafqir
AFNOR – How is a Notified Body designated?
Medical Device made Easy Podcast - June 18, 2024 00:00 ★★★★★ - 18 ratingsThe Notified Body is an important actor for Medical Devices that seek a CE certification under EU MDR and IVDR. In this Episode Thomas Lommatzsch from AFNOR will explain to us the difficult process of designation. The post AFNOR – How is a Notified Body designated? appeared first on Medical D...
Cleaning Validation – How to select the worst case?
Medical Device made Easy Podcast - June 11, 2024 00:00 ★★★★★ - 18 ratingsIf you are working within Surgical Instruments, or any products that need to be really clean prior to be sent, then this episode is for you. We discuss with Heena Thakkar what is the best way to manage cleaning validation. The post Cleaning Validation – How to select the worst case? appeared ...
Medical Device News June 2024 Regulatory Update
Medical Device made Easy Podcast - June 06, 2024 01:48 ★★★★★ - 18 ratingsThe post Medical Device News June 2024 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir
Summative Evaluation – Common mistakes
Medical Device made Easy Podcast - May 28, 2024 00:00 ★★★★★ - 18 ratingsIn 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 Medi...
Are you more Corrections or Corrective Actions or Preventive Actions?
Medical Device made Easy Podcast - May 21, 2024 00:00 ★★★★★ - 18 ratingsSometimes, 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 Act...
How to select and evaluate your Contract Manufacturer?
Medical Device made Easy Podcast - May 14, 2024 00:00 ★★★★★ - 18 ratingsSometimes, 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 Ma...
Quality Field Service for Medical Devices?
Medical Device made Easy Podcast - May 07, 2024 00:00 ★★★★★ - 18 ratingsSome 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?...
Quality Field Service for Medical Devices
Medical Device made Easy Podcast - May 07, 2024 00:00 ★★★★★ - 18 ratingsSome 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 ...
Medical Device NewsMAY 2024 Regulatory Update
Medical Device made Easy Podcast - May 02, 2024 10:27 ★★★★★ - 18 ratingsEU 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...
Why and how to build a Quality Culture?
Medical Device made Easy Podcast - April 23, 2024 00:00 ★★★★★ - 18 ratingsYou 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 buil...
What is the impact of AI Act on Medical Devices?
Medical Device made Easy Podcast - April 16, 2024 00:00 ★★★★★ - 18 ratingsWe 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 Medi...
Radiation Sterilisation Master File (ISO 11137 & 11607)
Medical Device made Easy Podcast - April 09, 2024 01:00 ★★★★★ - 18 ratingsAdam 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
Medical Device News April 2024 Regulatory Update
Medical Device made Easy Podcast - April 04, 2024 00:00 ★★★★★ - 18 ratingsSponsor: 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 Po...
How to benefit from Surveys to build Clinical Evidence?
Medical Device made Easy Podcast - March 26, 2024 00:00 ★★★★★ - 18 ratingsOn 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
How to do Postmarketing Surveillance the right way?
Medical Device made Easy Podcast - March 19, 2024 00:00 ★★★★★ - 18 ratingsOn 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
Learn more about FDA QMSR alignment with ISO 13485
Medical Device made Easy Podcast - March 12, 2024 00:00 ★★★★★ - 18 ratingsOn 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
Medical Device News March 2024 Regulatory Update
Medical Device made Easy Podcast - March 06, 2024 00:00 ★★★★★ - 18 ratingsEU 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
New EU Proposal – EUDAMED, IVDR & Shortage
Medical Device made Easy Podcast - February 27, 2024 01:00 ★★★★★ - 18 ratingsThe 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 appeare...
Will EtO gaz become a Medical Device?
Medical Device made Easy Podcast - February 20, 2024 00:00 ★★★★★ - 18 ratingsEtO 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
How to get your interview prepared?
Medical Device made Easy Podcast - February 13, 2024 00:00 ★★★★★ - 18 ratingsThe 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
Medical Device News february 2024 Regulatory Update
Medical Device made Easy Podcast - February 07, 2024 09:15 ★★★★★ - 18 ratingsThis 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 Devic...
Why you should use Pre-Submission or Q-Sub with FDA?
Medical Device made Easy Podcast - January 30, 2024 00:00 ★★★★★ - 18 ratingsIn 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 ...
You are not the Physical Manufacturer, can you be MDR certified?
Medical Device made Easy Podcast - January 23, 2024 00:00 ★★★★★ - 18 ratingsYou 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 – InterviewS with Startups, Service Providers, Notified Bodies…
Medical Device made Easy Podcast - January 18, 2024 10:02 ★★★★★ - 18 ratingsMedica 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 Po...
WARNING! APPLY TO YOUR NOTIFIED BODY NOW!
Medical Device made Easy Podcast - January 16, 2024 00:00 ★★★★★ - 18 ratingsThe 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! ...
Medical Device News – january 2024 Regulatory Update
Medical Device made Easy Podcast - January 10, 2024 00:00 ★★★★★ - 18 ratingsMedboard 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 Medi...
Regulatory Maturity Model – Heatmap (MEDICA 2023)
Medical Device made Easy Podcast - January 02, 2024 00:00 ★★★★★ - 18 ratingsA 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 Podca...
Life of QA RA Podcasters?
Medical Device made Easy Podcast - December 26, 2023 00:00 ★★★★★ - 18 ratingsEasy 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...
Why should you invest in your Regulatory Team?
Medical Device made Easy Podcast - December 18, 2023 23:35 ★★★★★ - 18 ratingsTo 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 mo...