Shows / Medical Device made Easy Podcast
Episodes
- Medical Device made Easy Podcast
February 2021 Update – Medical Devices Remote Audit by the EU
Subscribe In this monthly episode of the podcast, we do a regulatory intelligence review of what happened monthly. The agenda for this month is: Countdown…
- Medical Device made Easy Podcast
How to perform your PMS more easily with Ivan Perez Chamorro?
Subscribe PMS is one of the processes that is changing due to EU MDR and I wanted to come back to it with Ivan Perez Chamorro from MedBoard. MedBoard is a…
- Medical Device made Easy Podcast
How to get the MDR certification for Artificial Intelligence Softwares?
Subscribe Artificial Intelligence. This is the topic of today’s podcast episode. We will help you understand how to place AI Software as a Medical Device…
- Medical Device made Easy Podcast
How to register a Medical Device in Israel? (Liat Nadel)
Subscribe Registration of products in different countries is always a Challenge. And for Israel, this is the same. I have invited Liat Nadel from L.S…
- Medical Device made Easy Podcast
Medical Device News – January 2021 Update (Monir El Azzouzi)
Subscribe HAPPY NEW YEAR 2021 and all my best wishes to you and your family. Within this Medical Device News monthly episode of the podcast, we are reviewing…
- Medical Device made Easy Podcast
How Easy Medical Device can help you? (Monir El Azzouzi)
Subscribe In this episode of the Medical Device made Easy Podcast, I will share with you the progress of the Easy Medical Device project. I hope this will be…
- Medical Device made Easy Podcast
How to deal with Significant Changes within MDR & IVDR with Martin Witte
Subscribe If you are transitioning from the EU MDD 93/42/EC or 90/385/EEC to the EU MDR 2017/745 or from the IVDD 98/79/EC to the IVDR 2017/745, then you have…
- Medical Device made Easy Podcast
How to register a Medical Device in Mexico? [Josué Garza]
Subscribe The registration of Medical Devices is always different and this time we will explain to you how you can do that in Mexico. For that I have invited…
- Medical Device made Easy Podcast
Medical Device News: What happened in November 2020?
In this monthly review of Medical Device News, we will see what happened this November 2020 for the Medical Device Industry. During this review, we will check…
- Medical Device made Easy Podcast
Is it Easy for a Notified Body to get EU MDR accredited?
We talk a lot about Manufacturers that are under pressure because they cannot find a Notified Body, but today we will also talk about the pressure on Notified…
- Medical Device made Easy Podcast
How a Quality & Regulatory training can help you? [Sofmedica]
Subscribe I had the chance to train many people to EU MDR and I am always proud to see them implementing what they have learned. And today I want to tell you…
- Medical Device made Easy Podcast
Do you need an Expert Panel for your Medical Devices? [Bassil Akra]
The EU MDR 2017/745 is increasing the requirements for Clinical Evaluations. In this episode, I will be with Dr. Bassil Akra from QUNIQUE and we will explain…
- Medical Device made Easy Podcast
What are Common Specifications under EU MDR & IVDR?
What are Common Specifications? Is this the same as ISO standards or any other guidance? This is what we will review within this episode with Stefan…
- Medical Device made Easy Podcast
We’ve reached episode 100 – What happened for the last 2 years?
We have reached Episode 100 and when I am looking back, I can see that there were a lot of things done. But instead of me telling you only my story, I have…
- Medical Device made Easy Podcast
How to certify a self-testing device under IVDR? [Erik Vollebregt]
We have talked enough about EU MDR so this week we will help the IVD Companies with the requirements for Self-testing devices under IVDR. Self-tests or…
- Medical Device made Easy Podcast
What is the cost of EU MDR 2017/745? [Catherine Higginson]
Catherine Higginson from Climedo is coming on the Podcast to present us one study they have issued which will tell you more about the Cost of EU MDR but not…
- Medical Device made Easy Podcast
How to register your Medical Device in the ASEAN region?
The focused region is the region that agreed to follow the ASEAN regulation. ASEAN means the Association of South East Asia Nations. In this episode of the…
- Medical Device made Easy Podcast
The latest news on Brexit, Swixit and EU MDR [Medical Device News]
This month on the Medical Device News section of the podcast we will talk about: Exits from Europe with Brexit and Swixit Conferences that are now mainly going…
- Medical Device made Easy Podcast
How to register ATMP-Device combination products?
ATMP stands for Advanced Therapy Medicinal Products, which is a category of Medicinal Product. But if I combine this with a Medical Device, how should this be…
- Medical Device made Easy Podcast
How to get some help from Medical Device Regulators with Cliff Bleustein
In this episode, Cliff Bleustein, President and CEO of Apos Therapy is explaining to us all the process that his company followed to place his Medical Device…
- Medical Device made Easy Podcast
How can GDPR impact Medical Devices with Erik Vollebregt
There were a lot of discussions about GDPR since its implementation in early 2018. But after a few years, some issues are happening and this may impact the…
- Medical Device made Easy Podcast
Be successful at your MDR and IVDR audit with Martin Witte
If you are preparing for your EU MDR 2017/745 or IVDR 2017/746 audit, then this episode is for you. I have invited Martin Witte from TÜV SÜD to provide some…
- Medical Device made Easy Podcast
Medical Device News – August 2020 Review (Monir El Azzouzi)
The Medical Device industry is still moving a few steps forward to EU MDR 2017/745. Here is the agenda of this review: UDI Cardiac Implantable Electronic…
- Medical Device made Easy Podcast
How to switch quickly to a Virtual Conference with TOPRA
This year is a particular one for the Medical Device Industry and for the world. The pandemic changed completely our way to do things. What was difficult…
- Medical Device made Easy Podcast
Best practice for Device Testing with Michael Wetherington
When you are trying to develop a Medical Device, there is a stage that you cannot avoid which is testing your products. For that, I have invited Michael…
- Medical Device made Easy Podcast
Best overview of IEC 60601 for Medical Device electrical equipment
In this episode of the Medical Device made Easy Podcast, I have invited Leo Eisner from Eisner Security Consultants to help us understand the standards IEC…
- Medical Device made Easy Podcast
Medical Device News – July 2020 Update on Quality and Regulatory for Medical Devices
In this monthly episode of the podcast, we talk about all that happened to the Medical Device industry. This is the July 2020 Update. Within the Hot Topics, we…
- Medical Device made Easy Podcast
Learn UDI code for Medical Devices with Sylvia Reingardt
The UDI code is a new feature introduced by the EU MDR 2017/745 and IVDR 2017/746. It is here to increase traceability and transparency with its combination to…
- Medical Device made Easy Podcast
Understand IEC 62304 for Medical Device Software with Adnan Ashfaq
If you are developing Medical Device software then IEC 62304 is an important standard for you. In this episode, Monir El Azzouzi invited Adnan Ashfaq from…
- Medical Device made Easy Podcast
How to become a PRRC with TEAM-PRRC (EU MDR & IVDR)
The PRRC is a new role within the EU MDR 2017/745. All medical device companies need a person within their organization to be responsible for that. In this…
- Medical Device made Easy Podcast
Medical Device News – June 2020 Update
In the Medical Device News segment of the podcast, we will talk about what happened during the month of June. Each month we imagine that there is not a lot to…
- Medical Device made Easy Podcast
The secrets to being EU MDR certified with Shokoufeh Khodabandeh
We are talking a lot of time about how to be MDR certified and I provide you with some tips etc… In this episode of the Podcast, I wanted to interview…
- Medical Device made Easy Podcast
How to perform your Process Validation with Adnan Ashfaq (IQ OQ PQ)
Process Validation is a science but it needs also some education. In this episode of the Medical Device made Easy Podcast, we will help you understand what is…
- Medical Device made Easy Podcast
How to execute your Internal Audits? (Medical Device companies)
In this episode of the Medical Device made Easy Podcast, Monir El Azzouzi will explain to you how to perform Internal Audits for your company. Internal Audit…
- Medical Device made Easy Podcast
Medical Device News – May 2020 Review with Monir El Azzouzi
In this episode of the podcast, we will review what happened during the month of May 2020 for the Medical Device Industry. And there was a lot. The agenda: EU…
- Medical Device made Easy Podcast
What means Sufficient Clinical Data with Bassil Akra (EU MDR)
You are maybe trying to build your Clinical Evaluation Report or your PMCF for a Medical Device. And you are stuck because you don’t really understand…
- Medical Device made Easy Podcast
What is the Notified Body situation? (Bassil Akra from TUV SUD)
You are looking for a Notified Body for your Medical Device in the EU market but you don’t understand why this is so difficult. In this episode of the…
- Medical Device made Easy Podcast
How to get ISO 13485 certified? (Quality Management System)
In this episode of the Medical Device made Easy Podcast, I wanted to answer a recurring question I receive with as much detail as possible. The question is…
- Medical Device made Easy Podcast
How to get your Digital Health Application reimbursed in Germany? (DIGA)
In Germany, a new law was issued for Digital Health Application. To help us understand the content of this law, I have asked Stefan Bolleininger who is helping…
- Medical Device made Easy Podcast
Medical Device News – April 2020 Regulatory Update
In this episode of the Medical Device made Easy Podcast, we will review; How Coronavirus is shaking the Medical Device World? The Notified Body Situation The…
- Medical Device made Easy Podcast
How to calculate your sample size with Jon Bergsteinsson
When you are starting a study like a Clinical Trial or Clinical Investigation or PMCF, you arrive at a point where you need to define how many people need to…
- Medical Device made Easy Podcast
The 1-year delay for the EU MDR 2017/745 with Erik Vollebregt
This week I had some exciting moment when I followed the EU parlement webcast on the April 17th, plenary session to see what they will decide about the…
- Medical Device made Easy Podcast
Medical Device School – Why are Staff hiding problems to QA & RA?
If you are working for Quality then you maybe experienced this situation. And if you are an employee outside of Quality then we maybe understand why you are…
- Medical Device made Easy Podcast
MDR & Drug-Device Combination Products with Theresa Jeary
This episode will be really interesting for the pharmaceutical companies that are producing Drug-Device combination products as it explains the consequence of…
- Medical Device made Easy Podcast
Medical Device News – March 2020 Review (EU MDR)
In this episode of the Podcast, I will provide you with the situation for the month of march 2020 and what should happen next. As you may know we are in the…
- Medical Device made Easy Podcast
What is a Significant Change for your Medical Device? with Erik Vollebregt
This is a topic that all of you are talking about. What is a Significant Change to your Medical Device? I may say, it depends and this is also the answer of…
- Medical Device made Easy Podcast
All about Class Is, Im and Ir with Elem Ayne (EU MDR 2017/745)
We already talked on the podcast about the class I devices. But here I wanted to focus more on the sub-classes of class I products. There are 3 sub-classes…
- Medical Device made Easy Podcast
Cybersecurity for your Medical Devices with Erik Vollebregt
Let’s see if what is shown in movies is correct. Can some hackers take control of a Hospital or kill you by hacking an insulin pump. Is this science…
- Medical Device made Easy Podcast
Medical Device Regulatory Update – February 2020
On this Regulatory Update, we will talk about many diverse topics but here is an outline. First, we will review the Coronavirus situation and I will also…
- Medical Device made Easy Podcast
Do your Economic Operators need a Quality Management System?
We know that the Manufacturer of a Medical Device needs a Quality Management System, but what about the Importer, Distributor or Authorized Representative? Do…
- Medical Device made Easy Podcast
Create your intended purpose with Cesare Magri (Medical Device)
As Cesare Magri said, the intended purpose is not really a priority for some companies so they don’t take to much time to write them. But you will hear…
- Medical Device made Easy Podcast
Medical Device School: What should verify your Economic Operators?
We continue on this series about Economic Operators and this time we will let you understand what they should check. What an Importer, Distributor or…
- Medical Device made Easy Podcast
Clinical Data for Low Risk Medical Devices with Robert van Boxtel
We talked a lot about how to perform a Clinical Evaluation for your medical device. But when your device has a low risk and there is not enough data to prove…
- Medical Device made Easy Podcast
Medical Device School – Who controls your Economic Operators?
In this Medical Device School Bonus episode, Erik Vollebregt and Monir El Azzouzi are helping you to understand the way the Economic Operators are controlled…
- Medical Device made Easy Podcast
Are Brexit, Swixit, and Turkxit a reality? with Erik Vollebregt
Alert: Too much -xit will be mentioned in this episode of the Podcast. We apologize if some confusion happens. Monir El Azzouzi and Erik Vollebregt will help…
- Medical Device made Easy Podcast
Medical Device School – Who are your Economic Operators?
With MDR 2017/745 and IVDR 2017/746, we discover some new Vocabulary and one of them is clearly important to consider and this is “Economic…
- Medical Device made Easy Podcast
Swixit or not Swixit? this is the question with Ronald Boumans
We started to talk a lot about Brexit, but in the meantime for the Medical Device Industry, Swixit is starting to happen. This is for Switzerland Exist from…
- Medical Device made Easy Podcast
Medical Device School – Process Validation or Verification?
When you need to prove that your product conforms to the Specification, Process Validation or Verification is a good question you should ask yourself. Monir El…
- Medical Device made Easy Podcast
Episode 61 – Medical Device Regulatory Update: January 2020
In this episode of the Medical Device made Easy Podcast, we will review all the major updates that happened in the Medical Device world. I will try to gather…
- Medical Device made Easy Podcast
How to register your Device in Brazil with Tania Aprigliano? (ANVISA)
Are you considering Brazil as a country to register and distribute your Medical Devices? In this episode, we will give you all the information you need to make…