The use of a cleanroom is something that depends on your products. Philippe Bourbon from the laboratory Icare will explain to us what exactly is needed to install and maintain cleanrooms. The post Maybe you need a Cleanroom? Let’s check with Philippe Bourbon appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
If you are working with Artifical Intelligence for your Medical Devices, then this episode is for you. We are alerting you about the new legislation that is planned for all Artificial Intelligence software. Not only medical devices, but they are included. The post AI Act vs EU MDR 2017/745 are they compatible? [Erik Vollebregt] appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
During my visit to the Medtech Europe Forum I had the chance to meet Fabien, Peter, Ronald, Inna and Rana. They shared with me some great information. Don't miss their interview. The post Medtech Europe Forum interviews (MDR, EUDAMED, CER & MECOMED) appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
This podcast episode is the monthly review of the regulatory situation. Don't forget to download the document with all the links. The post Medical Device News – July 2022 Regulatory Update appeared first on Medical Device made Easy Podcast . Monir El Azzouzi
This is your last year to be compliant to UKCA otherwise Bye Bye the UK market. We tell you everything with Adam Rae on this episode. So listen carefuly and don't forget to download the cheat sheet. The post Attention! 1 year before UKCA is the law for Medical Devices in the UK appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
We may think that ISO 13485 certification is only for Medical Device manufacturers but in this episode you will hear Cristina Miroescu from Sofmedica Group tell us why its company decided to be certified even if they are not manufacturing devices. The post Why is it great for Importers to be ISO 13485 certified? [Cristina Miroescu] appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
Karandeep Badwal will list us some of the common mistakes that he has always noticed. I will confirm some of them. If you are able to solve those you have made already 70% of the problems resolved. Enjoy! The post What are some Quality Common Mistakes? [Karandeep Badwal] appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
Medical device news June 2022 is focusing on IVDR 2017/746 date of applciation and consequences. Don't miss all the additional information on guidances, Training,,, The post Medical Device News: June 2022 Regulatory Update appeared first on Medical Device made Easy Podcast . Monir El Azzouzi
We have worked since more than a year on an eQMS called SmartEye and I have invited Anindya Mookerjea the CEO of SCube Technologies to present the tool and talk about the advantages of electronic Quality Management Systems. The post Let’s introduce you to our eQMS SmartEye with Anindya Mookerjea appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
Medtech Forum was really a great event with all the Medical Device stakeholders at the same place. Manufacturers, Consultants, Notified Body, European Commission, trade associations, service providers. Let's summarize that with Erik Vollebregt. The post What to learn about the EU Medical Device situation? [Erik Vollebregt] appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
The IVDR 2017/746 will go live and this may be a big problem for a lot of companies. We will talk about that with Colm O'Rourke from Trinzo. The IVDR is changing the game so learn about it. The post What happens after the IVDR Date of Application with Colm O’Rourke appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
Software as a Medical Device is an area that is exploding. So understanding how this is working and what to be done is important. Listen to this episode to have more clarity on your projects for EU and US. The post How to certify your Software as a Medical Device? (SaMD) appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
In this episode, we will review all the changes related to Quality & Regulatory Affairs for Medical Devices in the month of May 2022. The post Medical Device News: May 2022 Regulatory Update appeared first on Medical Device made Easy Podcast . Monir El Azzouzi
Great episode with Rod and Katie on Training Requirements. A lot of afvices that can help you pass audits and remain compliant The post Training Process – What are the mistakes to avoid? [ISO 13485] appeared first on Medical Device made Easy Podcast . Monir El Azzouzi
This podcast episode will be instrumental for you as PMCF should be part of your strategy. And Matthias Fink from TÜV SÜD will provide you with great advice on how to overcome this task. The post How your PMCF is evaluated by your Notified Body? [Matthias Fink] appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
Have you ever performed an audit with a Front Room and Back Room? In this episode I will explain to you how this works and what is the interest. This method can help you to have a smooth audit and make your auditor happy. The post How to prepare an Audit with a Front Room & a Back Room? appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
The latest news for the Medical Device Community is on the Medical Device News Podcast. We'll talk about EU, US, MEA, Asia, Notified Bodies, Events, Podcasts. So enjoy! The post Medical Device News: April 2022 Update appeared first on Medical Device made Easy Podcast . Monir El Azzouzi
We update you on the situation regarding the MDR and IVDR transition period. Erik Vollebregt will try to provide an explanation why the EMA will now take the control of the Expert Panel for Medical Devices and also why the proposal for a 2 years or more additional transition will be needed. The post What are the surprises during MDR & IVDR transition? [Erik Vollebregt] appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
If you are selling medical devices online or if you plan to sell some, then this episode is for you. This will help you to understand the struggle that you may have or will encounter. Michael Wetherington and I will provide you the keys to be successful in that field. The post How to sell Medical Devices online in the EU and US? appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
If you are not sure of your Clinical Evaluation, then maybe by listening that you will have a better understanding of what is expected from you. So don't miss the lesson learned with Cesare Magri The post What lesson did we learn doing Clinical Evaluations? [Cesare Magri] appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
You will hear more and more about IVDR and now we talk of the Draft Common Specification. Have a look at the explanation from Andreas that will help you be more efficient if your products are on scope. The post Why do we need the Common Specification for Class D IVDR? appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
This month the big news is about FDA amending QSR to integrate ISO 13485. Not sure on how this will be at the end but it's always cool to have harmonization. No worries, other topics like IVDR, MDCG, UK, Saudi Arabia, Spain are mentioned. Enjoy!!! The post Medical Device News – March 2022 Regulatory Update appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
What is the role of a Swiss Authorized Representative and Swiss Importer? And most importantly why would you need one? I'll tell you everything on this podcast episode. The post Why would you need a Swiss Authorised Representative and Importer? appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
Management Review is one of the most important activity to perform before to be ISO 13485 certified. So today I will explain to you how to be great at it. The post How to be great at Management Reviews? [ISO 13485] appeared first on Medical Device made Easy Podcast . Monir El Azzouzi
DHF is an accronym that people don't really understand and in this episode Alexandros Savvidis he tries to help us have a view of his experience. The post Why Design History File (DHF) is so important? [Alexandros Savvidis] appeared first on Medical Device made Easy Podcast . Monir El Azzouzi
All the February 2022 updates on MDR and IVDR, Clinical requirements and some news on the guidances and Notified Bodies. The post Medical Device News: February 2022 Regulatory Update appeared first on Medical Device made Easy Podcast . Monir El Azzouzi
The use of certain wording can be a big problem and this is what we will describe here with this MDCG guidance that is not really clarifying the situation but creating more problems. Let us tell you. The post MDCG 2021-27 Placing on the market & Re-labelling with Erik Vollebregt appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
What is your method to perform an interview? You are not trained as a recruiter so how should you do to interview a QA RA Candidate. This is what Mitch Robbins will explain to you on this episode. So no more misses. The post How to interview your QA RA Candidates? [Mitch Robbins] appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
Lab Tests can be really tricky for the success of your Medical Device Design. We will help you in this episode to understand with Christoph Lindner. Check show notes for more details. The post How to accelerate your Laboratory Test Results? [Christoph Lindner] appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
HAPPY NEW YEAR 2022! Another year passed and this went really fast. But the Medical Device News is still here. So today we will talk of all the releases done in December 2021 and what is planned for the following months. Don't miss it. This will save you a lot of time. The post Medical Device News – January 2022 [Happy New Year] appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
