I know, already the end of 2021. So many things happened that this may be difficult to summarize. So I've tried to put my TOP information on this episode. I also share with you the new projects for Easy Medical Device so don't hesitate to contact us if you need our support. The post What happened in 2021? Summary for the Medical Device Industry appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
For this christmas season, I wanted to summaries the situation on how to get MDR & IVDR certified. So i made this step-by-step recipe where you just need to follow. I hope you'll enjoy. The post The Step-by-Step recipe to get MDR & IVDR Certified appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
If you are not aware, the EU MDR 2017/745 is completely changing the definition of Custom-made devices and this is mainly what we will try to explain to you on this episode. If you still have some question,s don't hesitate to contact me. The post Which devices cannot be Custom-made? [Erik Vollebregt] appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
Here is the last Medical Device News for this year, I will cover all the updates that happen in the EU, UK, Switzerland,, US and Saudi Arabia. We will also review the situation for Notified Bodies. I hope you'll enjoy. The post Medical Device News: December 2021 Regulatory Update appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
The MDR classification was hidding some surprises and I have asked Frank Matzek from Biotronik to tell us more about the products and rules we need to take care of. So Enjoy! The post Let’s unleash “MDR Classification surprises” [MDR 2017/745] appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
Really great discussion with Dr Royth von Hahn from TÜV SÜD. He is providing some solutions on how to talk to your Notified Body. This would help Medical Device manufacturers. The post How to approach your Notified Bodies? [Dr. Royth von Hahn – TÜV SÜD] appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
OEM OBL is really used a lot by Medical Device Manufacturers. But this is not possible anymore with EU MDR. So please listen to that as maybe you are doing it without knowing. The post Is it possible to Private Label a Medical Device under MDR & IVDR? appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
Lesley Worthington is a career coach and will help you understand why improving your communication skills within QA RA can be a booster for you. We will talk about our experience as she also worked in QA RA. So don't miss this episode if you don't understand why your communication activities are not helping you. The post How to improve your QA RA Communication with Lesley Worthington? appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
Latest update will focus on IVDR proposal, Artificial intelligence, Notified Bodies situation and MDCG guidances. Other elements will also be discussed. I hope you'll enjoy! The post Medical Device News – November 2021 latest update appeared first on Medical Device made Easy Podcast . Monir El Azzouzi
BREAKING NEWS: The EU Commission issued a proposal to delay some IVDR date of application but it is not a complete postponment so don't use this word. Listen the interpretation of Erik Vollebregt on that. The post How does the EU Commission plan to save IVDR 2017/746? appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
Ana Luiza is my guest and we will explain to you how to be sure that your are compliant with CMR substances on your product. CMR will be reviewed during an audit and apparently there were a lot of mistakes. So let's help you to avoid that. The post How to comply with MDR when products contain CMR Substances? appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
EUDAMED is the database that will provide all the information about your company and your devices. After the release of the Economic Operator module, now there is the release of the Device Registration and Certificate Module. So let's talk about that with Richard Houlihan from Eudamed.com The post EUDAMED Update: Should you register your medical devices now? appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
Here is the Regulatory update for October 2021. We will talk of the Implementation of MDR and IVDR, MHRA, Swissmedic, FDA, AEMPS.. A new session of the Green Belt opens this month. The post Medical Device News – October 2021 Regulatory Update appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
The MDR and IVDR has not finished to surprise us. On this episode we will talk about the article 16(4) where we see that in certain circumstances, an importer or Distributor will need to get certified by a Notified Body even if they are not doing a manufacturing activity. So don't miss that. The post Why does an Importer/Distributor need to appoint a Notified Body? appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
Are you starting a clinical investigation or PMCF? Then are you using a Digital Solution to collect the data? Today we will explain to you what is The post How to collect Clinical Data within the 21st Century [Jon Bergsteinsson] appeared first on Medical Device made Easy Podcast . Monir El Azzouzi
We have passed the Date of application for MDR and this went well because a lot of manufacturers do have CE certificates that expire later. But for IVDR this is another story. So for the majority of the products, they should be compliant by the date of application. Let me explain that to you on this episode. The post How to manage the IVDR transition period? [IVDR 2017/745] appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
Maybe some of dreamed of it, maybe this idea went through your mind but you haven't done it. Here we will talk with Erik Vollebregt of the consequences of opening a legal case with your Notified Body. The post Is it a good idea to sue my Notified Body? [Erik Vollebregt] appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
On this September 2021 update we will talk about FDA, MHRA, Swissmedic, ANSM, Fimea, MDCG guidances, New Notified Bodies... A lot to talk about so don't miss this update. If you are not willing to read the guidances, let me summarize it for you. The post Medical Device News – September 2021 Latest Updates appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
There are a lot of questions about Software as Medical Devices. So I have invited Dr. Abtin Rad from TÜV SÜD to give us more information about how to consider SaMD with the EU MDR 2017/745 The post How to Certify a Software as Medical Device? (Dr. Abtin Rad – TÜV SÜD) appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
This is a question I asked myself when I started my career. I am now an independant consultant but I started as a Full-time employee. So Smahan will help us understand which option can be the best for you. The post Better to be a Consultant or a Full-time employee? [Lifescience industry] appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
We talked a lot about MDR and tried to teach most of its requirements. And today we will continue by providing you with the Most Common Mistakes that are discovered by Notified Bodies. Martin Witte from TÜV SÜD will share with us the issues that are discovered by its team. Let's learn from it. The post What can we learn from the first MDR audits? [Martin Witte -TÜV SÜD] appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
This is already Mi-Year with the summer holiday. But EU Commission didn't sleep as there was a lot of MDCG guidance released. Let's review the agenda for this month and don't miss all the links. The post Medical Device News – August 2021 Regulatory Update [MDR & IVDR] appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
Vigilance Reporting is an important system to have within your quality management system. Even if you are still MDD, you need to comply to the MDR requirements for it. So I will help you for that. The post How to implement Vigilance Reporting for MDR and IVDR? appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
After receiving a lot of questions on System and Procedure pack we have decided to have a second episode on it with Erik Vollebregt. So let's review some special cases and also some feedback from the authorities. The post System and Procedure Pack the RETURN with Erik Vollebregt appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
Bassil Akra will help use interpret this first Expert Panel Opinion. Bassil already helped on a previous episode where we discussed about the creation of this Expert Panel. Let's review this first outcome and see the consequence of it for the industry. The post How to interpret the first Expert Panel Opinion? [Bassil Akra] appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
We will update you on all what happened within the Medical Device regulation. All new The post Medical Device News: The July 2021 Update [MDR IVDR FDA SFDA] appeared first on Medical Device made Easy Podcast . Monir El Azzouzi
The State-of-the Art is one of the component that can make you win or make you lose. If this research is not done correctly, it can ruin your Clinical Evaluation Report or Performance Evaluation Report. Hakan Inan from Requalite will explain to us why this is important. The post How to build your State-of-the-art for your Medical Devices? appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
In the case you are placing your brand trademark on a product, or if you buy a product designed by another company... then you need to understand the rules related to Intellectual properties. This episode with Stephen Carter will be a masterclass about Intellectual Property. The post How Intellectual Property is linked to the Medical Device Regulation? appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
Clinical Investigation is not really an easy process. So it can be important for your to understand what are the requirements and get some details about time and cost. Helene Quie from Qmed Consulting which is also a CRO will help us learn more about this process required by EU MDR. The post How to perform a good Clinical Investigation with Helene Quie appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
This podcast episode is really important as this answers some of the questions that a lot of my customers are asking. So I hope this will help you to understand why this is important to perform a Biological Evaluation or Biocompatibility for your finished product. The post How to perform a Biological Evaluation for your Medical Device? appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
