n this episode, Martin King will share with us his practice of AI in the context of Quality and Regulatory affairs for medical devices. This will explain to you some best practices to maintain to avoid some pitfalls. The post How to use AI GPT for your Quality and Regulatory work? appeared first on Medical Device made Easy Podcast . hamza benafqir...
In this episode, Stephen O’Rourke that was not working within the Medical Device industry will share with us is journey from Zero knowledge in the field to running projects. Listen to his journey in case you are also willing to breakthrough the medical device field. The post How to go from Zero to Hero in Medical Devices? appeared first on Medical Device made Easy Podcast . hamza benafqir...
: In this episode, I have invited Ralf Gansel to help us understand the process for Certification of your product and what is the lifecycle for it. We’ll discuss about Transfer or certificates, or notification of changes or why there is a renewal and not continuous surveillance… The post Manage the Transfer/Renewal/Surveillance/Change of your CE certificate appeared first on Medical Device made Easy Podcast . hamza benafqir...
In this episode, Beat Keller will help you understand Harmonized Standards and how to use them and also how to do when there is no Harmonized Standards. So stay tuned. The post How to use Harmonized Standards for Medical Devices? appeared first on Medical Device made Easy Podcast . hamza benafqir
TÜV SÜD is one of the main notified bodies. And they are celebrating their 100th Class D certificate. Andreas Stange will explain to us what they learned and how manufacturers can improve their certification process. The post IVDR Class D – Lesson learned from Notified Bodies appeared first on Medical Device made Easy Podcast . hamza benafqir...
The EU MDR is in constant update and this change on the interruption of supply of medical devices should be integrated. The post EU MDR Major update: Interruption or Discontinuation of supply! appeared first on Medical Device made Easy Podcast . hamza benafqir
How to register your Medical Devices in the UAE with Ahmed Hendawy from Registitute and Monir El Azzouzi from Easy Medical Device The post How to register your Medical Device in the UAE? appeared first on Medical Device made Easy Podcast . hamza benafqir
Medical Devices should follow regulations like EU MDR or IVDR but also some regulations that are also targeting some components like batteries. So for that there is EU Battery Regulation 2023/1542. Erik Vollebregt from Axon Lawyers will explain the impact of the regulation to your product. The post EU Battery Regulation – How to be ready? appeared first on Medical Device made Easy Podcast . hamza benafqir...
The AI Act will be soon officially published even if we know the text will not change. So let’s help you to be prepared for its implementation. Fabien Roy will explain the challenges that he has recognized. The post AI Act – What are the challenges for Medical Devices? appeared first on Medical Device made Easy Podcast . hamza benafqir...
Medboard EU UK Swiss MEDTECH CONF LIVE SESSION US Australia Saudi Arabia Malaysia South Africa PODCAST Social Media to follow The post Medical Device News, July 2024 Regulatory Update appeared first on Medical Device made Easy Podcast . hamza benafqir
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 Wega The post How to submit your AI/ML SAMD the right way? appeared first on Medical Device made Easy Podcast . hamza benafqir
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 Notified Body designated? appeared first on Medical Device made Easy Podcast . hamza benafqir...
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 Validation – How to select the worst case? appeared first on Medical Device made Easy Podcast . hamza benafqir...
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 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
