Medical Device made Easy Podcast Archiv
417 Episoden
1 Minute
In this episode we will talk about the UDI FAQ, the new regulation for reprocessing of single use devices, the EUDAMED actor module, the new Guidances released... A lot to discuss today.
The post Medical Device News – August 2020 Review (Monir El Azzouzi) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
The post Medical Device News – August 2020 Review (Monir El Azzouzi) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
Kevin Pay and Raluca Radu from TOPRA are helping us to understand how a virtual conference can bring the same type of experience as a normal one. This year the TOPRA Symposium will be virtual so you can assist to it without to travel. Let's listen how this will be organized,
The post How to switch quickly to a Virtual Conference with TOPRA appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
The post How to switch quickly to a Virtual Conference with TOPRA appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
Medical Device Testing is something all medical device manufacturers should perform. How can you prove that your device is safe and performing without that. So now how to do it? Michael Wetherington from Medical Regs will be my guest on this episode of the podcast. He will share with us all best practices.
The post Best practice for Device Testing with Michael Wetherington appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
The post Best practice for Device Testing with Michael Wetherington appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
IEC 60601 is one of the most important standard to look at if you have an electrical medical devices.
In this episode Leonard Eisner also called the IEC 60601 guy will help us understand the full situation. So be ready to learn a lot today.
The post Best overview of IEC 60601 for Medical Device electrical equipment appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
In this episode Leonard Eisner also called the IEC 60601 guy will help us understand the full situation. So be ready to learn a lot today.
The post Best overview of IEC 60601 for Medical Device electrical equipment appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
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. Monir El Azzouzi
The post Medical Device News – July 2020 Update on Quality and Regulatory for Medical Devices appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
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. Monir El Azzouzi
The post Learn UDI code for Medical Devices with Sylvia Reingardt appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
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. Monir El Azzouzi
The post Understand IEC 62304 for Medical Device Software with Adnan Ashfaq appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
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. Monir El Azzouzi
The post How to become a PRRC with TEAM-PRRC (EU MDR & IVDR) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
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. Monir El Azzouzi
The post Medical Device News – June 2020 Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
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. Monir El Azzouzi
The post The secrets to being EU MDR certified with Shokoufeh Khodabandeh appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
Process Validation is an important but difficult topic. You should not only be good at engineering but also at explaining to your staff. Because a good validation worth nothing if the Staff is not following the instruction. Listen to Monir El Azzouzi and Adnan Ashfaq sharing with you their experience.
The post How to perform your Process Validation with Adnan Ashfaq (IQ OQ PQ) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
The post How to perform your Process Validation with Adnan Ashfaq (IQ OQ PQ) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
In this episode, I will help you understand the power of Internal Audits. Some of you are using that just because ISO is requiring it but you can get so much out of it.
The post How to execute your Internal Audits? (Medical Device companies) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
The post How to execute your Internal Audits? (Medical Device companies) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
The Month of May 2020 was supposed to be the beginning of the EU MDR. This was not as the new date is on May 26th, 2021. We will celebrate the Non-Anniversary of it and also talk about IVDR, MDCG, Notified Bodies, Coronavirus, Easy Medical Device podcast, LinkedIn Live... So be ready and push play.
The post Medical Device News – May 2020 Review with Monir El Azzouzi appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
The post Medical Device News – May 2020 Review with Monir El Azzouzi appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
Sufficient Clinical Data is a new vocabulary introduced with the EU MDR 2017/745 but this is still unclear what is sufficient and what is too weak.
Bassil Akra from QUNIQUE Group will explain to you what you should do in the episode where a former Notified Body employee is giving you advises related to his experience. Bassil is also offering a webinar to people that want to learn more about sufficient clinical data.
The post What means Sufficient Clinical Data with Bassil Akra (EU MDR) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Bassil Akra from QUNIQUE Group will explain to you what you should do in the episode where a former Notified Body employee is giving you advises related to his experience. Bassil is also offering a webinar to people that want to learn more about sufficient clinical data.
The post What means Sufficient Clinical Data with Bassil Akra (EU MDR) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
If you are looking for a Notified Body for your Medical Device, you maybe have some difficulties to find one. In this episode, Bassil Akra from TÜV SÜD will explain to you the reason of this.
The post What is the Notified Body situation? (Bassil Akra from TUV SUD) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
The post What is the Notified Body situation? (Bassil Akra from TUV SUD) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
