98 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

    • Careers
    • 4.0, 2 Ratings

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 News – July 2020 Update on Quality and Regulatory for Medical Devices

    Medical Device News – July 2020 Update on Quality and Regulatory for Medical Devices

    In this monthly update we will review some hot topics that happened within the last weeks., the Notified Body Situation, the Guidance and standards update and finally what happened at Easy Medical Device. The post Medical Device News – July 2020 Update on Quality and Regulatory for Medical Devices appeared first on Medical Device made Easy Podcast.

    Learn UDI code for Medical Devices with Sylvia Reingardt

    Learn UDI code for Medical Devices with Sylvia Reingardt

    UDI is new for Europe but already exist in the USA. We will explain to you what is important to understand for the EU version as there are some differences. Sylvia Reingardt from GS1 will be my guest and will share with us her knowledge and how GS1 can help. The post Learn UDI code for Medical Devices with Sylvia Reingardt appeared first on Medical Device made Easy Podcast.

    Understand IEC 62304 for Medical Device Software with Adnan Ashfaq

    Understand IEC 62304 for Medical Device Software with Adnan Ashfaq

    What is IEC 62304? This is the question I asked Adnan Ashfaq from Pharmi Med Ltd. The answer is helping a lot to understand the interaction with other standards and regulations. Enjoy it! The post Understand IEC 62304 for Medical Device Software with Adnan Ashfaq appeared first on Medical Device made Easy Podcast.

    How to become a PRRC with TEAM-PRRC (EU MDR & IVDR)

    How to become a PRRC with TEAM-PRRC (EU MDR & IVDR)

    Team-PRRC is invited to this episode to help us understand how to become a PRRC. This is a new role required for Medical Device manufacturers. In this episode, we will also share with you what TEAM-PRRC can do to help you. The post How to become a PRRC with TEAM-PRRC (EU MDR & IVDR) appeared first on Medical Device made Easy Podcast.

    Medical Device News – June 2020 Update

    Medical Device News – June 2020 Update

    During this update, we will talk about the Coronavirus situation, the Notified Body accredited, the CEN CENELEC mandate for Harmonized Standards, the Green Belt Certification Program. A lot to say and also a Trailer for the EU Commission Telenovela. The post Medical Device News – June 2020 Update appeared first on Medical Device made Easy Podcast.

    The secrets to being EU MDR certified with Shokoufeh Khodabandeh

    The secrets to being EU MDR certified with Shokoufeh Khodabandeh

    Shokoufeh from Straumann in Switzerland is sharing with us her journey on the EU MDR world. She will tell us what helped the team to reach this success and what she would have changed. The post The secrets to being EU MDR certified with Shokoufeh Khodabandeh appeared first on Medical Device made Easy Podcast.

Customer Reviews

4.0 out of 5
2 Ratings

2 Ratings

Crashes on iPhone 4 ,

Helpful information about medical device software validation

This was really helpful thank you. It would have been great to hear thoughts on Agile software development. The guests didn’t indicate that a certain methodology should be used but talking about phases indicates that a waterfall approach is assumed. As a software tester having experience in both methodologies, I believe you get much higher quality from an Agile approach so would have liked to hear how they think verification and validation should work in these environments.

Top Podcasts In Careers

Listeners Also Subscribed To