Medical Device made Easy Podcast

Medical Device made Easy Podcast

Listen Medical Device Regulation and Standards

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Episoder(405)

AI Act – What are the challenges for Medical Devices? 

AI Act – What are the challenges for Medical Devices? 

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 recog...

9 Jul 20240s

Medical Device News, July 2024 Regulatory Update

Medical Device News, July 2024 Regulatory Update

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 o...

5 Jul 20240s

How to submit your AI/ML SAMD the right way?

How to submit your AI/ML SAMD the right way?

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 ...

25 Jun 20240s

AFNOR – How is a Notified Body designated? 

AFNOR – How is a Notified Body designated? 

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...

18 Jun 20240s

Cleaning Validation – How to select the worst case? 

Cleaning Validation – How to select the worst case? 

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 manag...

11 Jun 20240s

Medical Device News June 2024 Regulatory Update

Medical Device News June 2024 Regulatory Update

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

6 Jun 20240s

Summative Evaluation – Common mistakes 

Summative Evaluation – Common mistakes 

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...

28 Mai 20240s

Are you more Corrections or Corrective Actions or Preventive Actions?

Are you more Corrections or Corrective Actions or Preventive Actions?

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 ...

21 Mai 20240s

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