In this first episode of 2021 we provide you an update of the Medical Device Regulation situation. We will talk about Brexit, Swixit, Turkxit, MDCG, Notified Bodies, Approved Bodies, Trainings, Podcast... A lot to cover. The post Medical Device News – January 2021 Update (Monir El Azzouzi) appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
This is the last episode of 2020 and I wanted to share with you the progress of the Easy Medical Device project. I will also tell you the next steps that I will try to achieve. Let me know how I can help you? The post How Easy Medical Device can help you? (Monir El Azzouzi) appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
Martin Witte from TÜV SÜD will help us to understand the significant changes to your devices and the consequence of it for your CE Certificate. You will have to listen carefully if you are selling medical devices on the EU market after May 26th, 2021 under your EU MDD certificate. The post How to deal with Significant Changes within MDR & IVDR with Martin Witte appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
You maybe know how to register your devices in Europe or USA now. But let's discover how we can do that in Mexico with Josué Garza from IPS or Insumos para la salud. You'll learn the 3 pathways to do that. The post How to register a Medical Device in Mexico? [Josué Garza] appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
This November update is providing a lot of information on what you should not miss. We will talk Brexit, Eudamed, Jobs, Training... A lot of topic to help you stay up-to-date. The post Medical Device News: What happened in November 2020? appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
In this episode, we will hear the journey of a Notified Body to get EU MDR accredited. We hope this will help you to understand how difficult it is and why you should be patient with your Notified Body. The post Is it Easy for a Notified Body to get EU MDR accredited? appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
In this episode, we will tell you why this is important to invest on trainings for your employees. I have invited a company that participated to the Green Belt Certificate and I asked them to tell us what they have implemented after taking this training. The post How a Quality & Regulatory training can help you? [Sofmedica] appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
If you thought that clinical evaluation was already difficult to work on with the new EU MDR, then listen to this episode where we will tell you about the new level of difficulty that is coming soon. The post Do you need an Expert Panel for your Medical Devices? [Bassil Akra] appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
Common Specifications are a type of regulation that we will explain to you in this episode with Stefan Bolleininger. The one on Reusable single use device was published. We expect more to come. The post What are Common Specifications under EU MDR & IVDR? appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
We have reached 100 episodes on the podcast and today we will celebrate that. Here is an episode with some of the great influencers in the Medical Device field which are sharing with us their journey. What happened to you since the last years. The post We’ve reached episode 100 – What happened for the last 2 years? appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
Self-testing devices are already existing in the market and already mentioned under IVDD. But what does change with the new IVDR? Erik Vollebregt from Axon Lawyers will help us to interpret that. The post How to certify a self-testing device under IVDR? [Erik Vollebregt] appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
EU MDR is a new regulation and if you have not started a project like that you need to understand that it is costing. Not only money but time, resource... So listen to this episode if you want to understand what you can expect from this type of projects. The post What is the cost of EU MDR 2017/745? [Catherine Higginson] appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
Michael Wetherington will by your instructor in this episode. He will provide you all the information to register your product in the ASEAN region. This is the countries located in the South East Asia. The post How to register your Medical Device in the ASEAN region? appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
This month a lot of exists on the Medical Device news. We are still under a pandemic so conferences are going virtual and Easy Medical Devices has the best training for EU MDR. The post The latest news on Brexit, Swixit and EU MDR [Medical Device News] appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
ATMP is a category of product not so well known by the regulatory affairs professionals. I wanted to help you understand how they are working with Margareth Jorvid. She will provide us with a specific overview for ATMP-Device combination products. The post How to register ATMP-Device combination products? appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
In this case study we will see how Apos Therapy was able to register his product in the US for certain therapy. Cliff Bleustein; President and CEO of Apos Therapy is my guest today and you'll see that for a CEO he knows a lot about regulatory affairs. The post How to get some help from Medical Device Regulators with Cliff Bleustein appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
GDPR is not specific to medical devices, but any judgment that is issued can impact devices. And this is the case with the SHREMS II case. Erik Vollebregt accepted to answer my questions on this technical topic to help us understand how to remain compliant. The post How can GDPR impact Medical Devices with Erik Vollebregt appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
The audit for a Medical Device company can be a real struggle if this was not correctly prepared. If you want to understand what a Notified Body is looking for when it is coming to your company, then you should listen to Martin Witte from TÜV SÜD. Who better than a Notified Body to tell you what a Notified Body wants to see. The post Be successful at your MDR and IVDR audit with Martin Witte appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
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...
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...
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...
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 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...
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...
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...
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...
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...
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...
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...
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...
