PODCAST

Medical Device made Easy Podcast

Monir El Azzouzi

Listen Medical Device Regulation and Standards

business management & marketing

All Episodes

Medical Device News December 2024 Regulatory Update

Medical Device made Easy Podcast ·

2024/12/12

MEDBOARD: https://www.medboard.com/ EUROPE SMARTEYE – Eqms Smarteye: https://eqms-smarteye.com/ EVENTS – Arab Health – January 27 to 30th, 2025: https://medtechconf.com/event/total-radiology-conference/ TRAINING ROW • Webinar January 14, 2025 – https://www.fda.gov/medical-devices/cdrhnew-news-andupdates/webinar-final-guidance-marketing-submission-recommendations-predetermined-change-control-plan?utm_source=FDALinkedin PODCAST Social […]The post Medical Device News

en-US

PCCP – The Magic tool for SaMD in the US?

Medical Device made Easy Podcast ·

2024/12/05

In this episode, Maria Diez from CMGMedDev is explaining to us the PCCP tool for SaMD and why it can help a lot. The post PCCP – The Magic tool for SaMD in the US? appeared first on Medical Device made Easy Podcast. hamza benafqir

en-US

How MDR and IVDR code can save you money?

Medical Device made Easy Podcast ·

2024/11/07

In this episode, Stefan Bolleininger will explain you can save money on your MDR or IVDR submission just by choosing the right MDR or IVDR code and by following some of his advice. The post How MDR and IVDR code can save you money? appeared first on Medical Device made Easy Podcast. hamza benafqir

en-US

What does a strategy for regulatory compliance looks...

Medical Device made Easy Podcast ·

2024/10/24

In this episode, Adam Isaacs Rae will help us shape your Regulatory Compliance Strategy. This is a requirement of the EU MDR and IVDR but it doesn’t provide much information. So let’s review that together. The post What does a strategy for regulatory compliance looks like? appeared first on Medical Device made Easy Podcast. hamza benafqir

en-US

Medical Device News, October 2024 Regulatory Update

Medical Device made Easy Podcast ·

2024/10/10

Medboard: https://www.medboard.com/ EUROPE EVENTS NB ROW Middle East Northern America South America: PODCAST Social Media to followThe post Medical Device News, October 2024 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir

en-US

Manage the Transfer/Renewal/Surveillance/Change of...

Medical Device made Easy Podcast ·

2024/08/20

: 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

en-US

How to use Harmonized Standards for Medical Devices?

Medical Device made Easy Podcast ·

2024/08/14

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

en-US

IVDR Class D – Lesson learned from Notified Bodies

Medical Device made Easy Podcast ·

2024/08/06

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

en-US

How to register your Medical Device in the UAE?

Medical Device made Easy Podcast ·

2024/07/23

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

en-US

EU Battery Regulation – How to be ready?

Medical Device made Easy Podcast ·

2024/07/16

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

en-US

Cleaning Validation – How to select the worst case?

Medical Device made Easy Podcast ·

2024/06/11

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

en-US

Medical Device News June 2024 Regulatory Update

Medical Device made Easy Podcast ·

2024/06/06

The post Medical Device News June 2024 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir

en-US

Medical Device NewsMAY 2024 Regulatory Update

Medical Device made Easy Podcast ·

2024/05/02

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 NewsMAY 2024 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir

en-US

Why and how to build a Quality Culture?

Medical Device made Easy Podcast ·

2024/04/23

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

en-US

What is the impact of AI Act on Medical Devices?

Medical Device made Easy Podcast ·

2024/04/16

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

en-US

Radiation Sterilisation Master File (ISO 11137 & 11607)

Medical Device made Easy Podcast ·

2024/04/09

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

en-US

How to benefit from Surveys to build Clinical Evidence?

Medical Device made Easy Podcast ·

2024/03/26

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

en-US

How to do Postmarketing Surveillance the right way?

Medical Device made Easy Podcast ·

2024/03/19

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

en-US

Learn more about FDA QMSR alignment with ISO 13485

Medical Device made Easy Podcast ·

2024/03/12

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

en-US

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Medical Device made Easy Podcast

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