Medical Device made Easy Podcast

AI Act – What are the challenges for Medical Devices?


Listen Later

I am an EU pharma/device lawyer and problem solver. My practice focuses on European Union (EU) and national regulatory matters involving medical devices and pharmaceutical laws and guidelines. I am following very closely the new regulations on medical devices (MDR and IVDR), the GDPR and regularly advise clients in relation to the requirements applicable to their digital health technologies. I focus particularly on the different stages of the medical device CE marking process and advise on a wide variety of topics which include the following: - determination of the appropriate classification of individual products; - clinical investigation procedure (e.g. authorisation from the EU Member States competent authorities, opinion from Ethics Committee, amendment to the Protocol, informed consent, serious adverse event qualification and notification, handling of personal data); - drafting of clinical investigation and clinical trial agreements, distribution agreements and contract manufacturing agreements; -clinical data requirements and clinical evaluation; - conformity assessment procedure; - review of Instruction For Use, products' labelling and promotional material including websites; - post-marketing surveillance activities including the notification of adverse event, product recall or product withdrawal; - preparation and review of technical documentation; - reimbursement. I also advise on questions regarding marketing authorisation procedures, variation procedures, and clinical trials, promotional and marketing activities in the pharmaceutical sector. Specialties: Regulation of medical devices and medicinal products in the EU

 Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.

 Links from the Video

Fabien Roy Linkedin Profile: https://www.linkedin.com/in/fabien-roy-83b55021/

Company Website:   

Ai Act text: 

 Social Media to follow

 Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi

 Twitter:

https://twitter.com/elazzouzim

 Pinterest: https://www.pinterest.com/easymedicaldevice

 Instagram: https://www.instagram.com/easymedicaldevice

 

...more
View all episodesView all episodes
Download on the App Store

Medical Device made Easy PodcastBy easymedicaldevice

  • 4.8
  • 4.8
  • 4.8
  • 4.8
  • 4.8

4.8

20 ratings


More shows like Medical Device made Easy Podcast

View all
Marketplace Tech by Marketplace

Marketplace Tech

1,268 Listeners

This American Life by This American Life

This American Life

90,802 Listeners

Planet Money by NPR

Planet Money

30,734 Listeners

The Meaningful Money Personal Finance Podcast by Pete Matthew

The Meaningful Money Personal Finance Podcast

85 Listeners

No Such Thing As A Fish by No Such Thing As A Fish

No Such Thing As A Fish

4,812 Listeners

Global Medical Device Podcast powered by Greenlight Guru by Greenlight Guru + Medical Device Entrepreneurs

Global Medical Device Podcast powered by Greenlight Guru

91 Listeners

The Daily by The New York Times

The Daily

110,865 Listeners

Women at Work by Harvard Business Review

Women at Work

1,396 Listeners

Career Diaries by Elemed by Elena Kyria

Career Diaries by Elemed

1 Listeners

Medical Device Insights by Prof. Dr. Christian Johner

Medical Device Insights

0 Listeners

The Rest Is History by Goalhanger

The Rest Is History

12,964 Listeners

Huberman Lab by Scicomm Media

Huberman Lab

28,531 Listeners

Let's Combinate - Drugs + Devices by Subhi Saadeh

Let's Combinate - Drugs + Devices

13 Listeners

NEJM AI Grand Rounds by NEJM Group

NEJM AI Grand Rounds

52 Listeners

Making Money by Damien Jordan & Timeyin Akerele from Most

Making Money

9 Listeners