Medical Device made Easy Podcast
A weekly podcast
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Medical Device made Easy Podcast
Episodes
Medical Device made Easy Podcast
A weekly podcast
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Episodes of Medical Device made Easy Podcast
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As 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 WegaThe post How to submit your AI/ML SAMD the right way? appeared first on Medical Device made E
The 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 Not
If 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 Va
The post Medical Device News June 2024 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir
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 E
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.
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. T
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.
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.
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 PodcastThe post Medical Device NewsM
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 co
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 Volleb
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 Medica
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 followThe post Medical Device News April 2024 Regulatory U
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. h
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. hamz
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
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 Po
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 202
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 Pr
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 Bo
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