132 episodes

On the Medical Device made Easy Podcast you'll learn how to place a compliant medical device on the market. I will share with you my experience and one of my guests. I am Monir El Azzouzi a Medical Device Expert specialized in Quality and Regulatory Affairs. I am also the founder of the Medical Device blog called Easy Medical Device where I try to teach to people the basics of Medical Devices. One of my Motto is "Would I give this product to a Member of my family" and I try to share this philosophy with all my community. If you are trying to learn more or to change your career to enter the medical device world, you should be part of my community. I will be your guide and will help you reach your objectives. Regulation is changing all over the world and this is hitting all medical device manufacturers. They need your help so learn and apply.

Medical Device made Easy Podcast Monir El Azzouzi

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On the Medical Device made Easy Podcast you'll learn how to place a compliant medical device on the market. I will share with you my experience and one of my guests. I am Monir El Azzouzi a Medical Device Expert specialized in Quality and Regulatory Affairs. I am also the founder of the Medical Device blog called Easy Medical Device where I try to teach to people the basics of Medical Devices. One of my Motto is "Would I give this product to a Member of my family" and I try to share this philosophy with all my community. If you are trying to learn more or to change your career to enter the medical device world, you should be part of my community. I will be your guide and will help you reach your objectives. Regulation is changing all over the world and this is hitting all medical device manufacturers. They need your help so learn and apply.

    Will it be really difficult for IVD manufacturers? [IVDR 2017/746]

    Will it be really difficult for IVD manufacturers? [IVDR 2017/746]

    IVDR is planned for May 26th, 2022 but why it will be more difficult for IVD manufacturers than for MDR manufacturers? Listen to this episode to have a better understanding The post Will it be really difficult for IVD manufacturers? [IVDR 2017/746] appeared first on Medical Device made Easy Podcast.

    How to create a Label under MDR? (Questions & Answers)

    How to create a Label under MDR? (Questions & Answers)

    During the Greenlight Guru summit on EU MDR & IVDR I have presented the way to create a label. And following the session there was so many questions that I decided to answer to some of them within the Podcast so everyone can benefit from it. So I hope this will help. The post How to create a Label under MDR? (Questions & Answers) appeared first on Medical Device made Easy Podcast.

    How System and Procedure Pack are regulated under EU MDR?

    How System and Procedure Pack are regulated under EU MDR?

    The system and procedure pack within EU MDR is still a mystery for a lot of people and Erik Vollebregt accepted to help us have a better understanding of this specific cases. We will explain to you what it is and who can use it. The post How System and Procedure Pack are regulated under EU MDR? appeared first on Medical Device made Easy Podcast.

    How to import your Medical Devices with an Independent Importer?

    How to import your Medical Devices with an Independent Importer?

    In this episode, Edgar Kasteel will help us understand the role of an importer and will also tell us more about the model of independent importers. The post How to import your Medical Devices with an Independent Importer? appeared first on Medical Device made Easy Podcast.

    What is the Medical Device News? [March 2021 update]

    What is the Medical Device News? [March 2021 update]

    In this monthly episode we will review what happened within the Medical Device industry. EUDAMED, Covid19, Notified Bodies... The post What is the Medical Device News? [March 2021 update] appeared first on Medical Device made Easy Podcast.

    The best design methods for successful development? [Jon Speer]

    The best design methods for successful development? [Jon Speer]

    Waterfall or Agile? Jon Speer from Greenlight Guru will help to understand what is the best methodology that can be used to develop your medicaldevices. The post The best design methods for successful development? [Jon Speer] appeared first on Medical Device made Easy Podcast.

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