In this episode, Richard Houlihan will explain to us the current situation about EUDAMED. This is the new European Database for Medical Devices and a lot of people are asking to start the registration on EUDAMED. But EUDAMED is not complete for the moment, so should we rush? When will this been mandatory? Let’s review that together. The post What is the EUDAMED Updates? appeared first on Medical Device made Easy Podcast . hamza benafqir...
In this second part of this podcast series on Team-Prrc interviews. we have 3 additional guests. Don’t miss the first one where we also got great interviews. In this episode, […] The post Interviews on Being The PRRC (Part 2) appeared first on Medical Device made Easy Podcast . hamza benafqir
This month we will review all what happened in the Medical Device world during the last weeks and what will happen in the next weeks. Check that The post MEDICAL DEVICE NEWS – SEPTEMBER 2023 Regulatory Update appeared first on Medical Device made Easy Podcast . hamza benafqir
If your Medical Device needs to be cleaned then it means that you need to prove that the cleaning method you propose is working. So how to do that? A laboratory can help for this by testing your method. But what can be some traps to that? Let’s listen to Enrico Allegra from TestLabs to understand how you can do this action in a safe mode. The post How to perform your Cleaning Validation in practice? appeared first on Medical Device made Easy Podcast . hamza benafqir...
We all want to follow EU MDR 2017/745 but for that you need to have clinical data and a clinical evaluation. But what are the acceptance criteria for it? Who defines the rules? Can this evolve? All these questions will be answered on this podcast with Cesare Magri from 4BetterDevices. The post What are the Acceptance Criteria for your Clinical Evaluation? appeared first on Medical Device made Easy Podcast . hamza benafqir...
Did you had this blank in your head when an auditor asked you the validation documents of your software? I know your pain. So today we will try to help you validate your software with some automation. For that I have invited Christophe Girardey from Wega to help move on that direction The post Why you should automate your Software validation? appeared first on Medical Device made Easy Podcast . hamza benafqir...
We feel your pain when your bosses ask you to hire a QA RA person, but the challenge is that there is no Budget for it. But you want to impress them, so what to do. In this episode Mitch Robbins a professional recruiter is telling you what to do. But don’t think this will be easy. The post Hire your QA RA person with no Budget appeared first on Medical Device made Easy Podcast . hamza benafqir...
Everyone is talking about Risk Management file and ask you to provide that to them. But should you do that alone or identify the best partners on your team to be successful. This is what Naveen Agarwal from Creative Analytics Solutions LLC is sharing with us today. The post Who should be on your Risk Management Dream Team? appeared first on Medical Device made Easy Podcast . hamza benafqir...
There is still this misunderstanding about AI, and we wanted to discuss about AI for Medical Devices to really understand what this is. I have invited Christophe Girardey from Wega to put some light in the dark. The post Artificial Intelligence in the Medical Device Industry appeared first on Medical Device made Easy Podcast . hamza benafqir...
Software validation when used on patient is common and mandatory. But now when we tell you that you should validate also the software you are using to record your documents, CAPAs, or work on the elements related to the product, then this start to be a bit tricky. Medical Device companies are not used to such requirements and we will explain how they should proceed on this podcast. The post Validation of Quality Software in Medical Devices appeared first on Medical Device made Easy Podcast . ham...
Saudi Arabia is a major actor in the Medical Device world. A lot of companies are willing to enter this market that can help them to reach also other regions of the Middle East. We will discuss with Ahmed Hendawy from Registitute about the way to register your medical devices with SFDA authorities. The post How to register Medical Devices in Saudi Arabia? appeared first on Medical Device made Easy Podcast . hamza benafqir...
july 2023regulatory update The post Medical Device News – July 2023 Regulatory Update appeared first on Medical Device made Easy Podcast . hamza benafqir
UK decided to add more time to implement the UKCA. Apparently, the EU amendment to extend the EU MDR and IVDR was also something they looked at to define their timeline. So, let’s see what will this mean for manufacturers with Alex Denoon, partner at the law firm Bristows. The post What should you know on UKCA extension appeared first on Medical Device made Easy Podcast . hamza benafqir...
You may be on the business of Software development and you ask yourself why your Dev team is not really happy to work with Quality and Regulatory affairs team? In this episode, we will discuss with Christophe Girardey from WEGA about the gaps and how this can be solved. The post How to connect Software dev and QA RA Team appeared first on Medical Device made Easy Podcast . hamza benafqir...
Since the EU MDR extension was voted, there are still a lot of questions remaining. This is what we will try to clarify today with Florian Tolkmitt from Pro-Liance. This podcast will provide you some tips or help you avoid some great misunderstanding. The post The great misunderstanding of EU MDR amendments appeared first on Medical Device made Easy Podcast . hamza benafqir...
Medical Device News - june 2023 regulatory update The post Medical Device News -June 2023 regulatory update appeared first on Medical Device made Easy Podcast . hamza benafqir
We all need to keep ourselves up to date. But how to access reliable information and how often should a check be done. This is what we will discuss with Ivan Perez Chamorro from MedBoard. You will get some hints on how to optimize your search. The post How to master Regulatory Intelligence? appeared first on Medical Device made Easy Podcast . hamza benafqir...
I know this is not really something that people anticipate. But the EU MDR is asking you to anticipate that. So don’t miss this as this can raise a Non-Conformance from the Notified Body during an audit if there is no plan in place. So do check what we propose to you. The post What if your Medical Device Company goes Bankrupt? appeared first on Medical Device made Easy Podcast . hamza benafqir...
Technical Files inconsistency, it is when your technical file is not providing the right information or that all the information is not aligned. Here we will try to look at some of these issues. The post Technical Files Inconsistencies Identified by Notified Bodies appeared first on Medical Device made Easy Podcast . hamza benafqir...
We hear so many things about UK and the timeline and now that EU issued an extension, the question is “Does this change something for UK” So on this episode we’ll review again what are the requirements to go to the UK market. The post The truth about the UK vs EU situation appeared first on Medical Device made Easy Podcast . hamza benafqir...
Medical Device news - May 2023 Regulatory Update- easy medical device The post Medical Device news – May 2023 Regulatory Update appeared first on Medical Device made Easy Podcast . hamza benafqir
We start to talk more and more of Software as Medical Device or SaMD. This time we will check with you how to develop a Software and transition to the Agile methodology with the company IronRooster. The post Transition to Agile for Software as Medical Device appeared first on Medical Device made Easy Podcast . hamza benafqir...
If you are selling a Medical Device that is not a class I, then you know that you have to go through an audit with a Notified Body. So let’s discuss how you should be prepared for that with Karandeep Badwal. The post Prepare your audit like a PRO appeared first on Medical Device made Easy Podcast . hamza benafqir...
In this context SOUP is not a dish but Software Of Unknown Provenance which is the term used for Software that was not created by you. Christian Kaestner from Medical Device HQ will explain to us what you should consider when you have a SOUP within your product. The post What is a SOUP for your Software Development? appeared first on Medical Device made Easy Podcast . hamza benafqir...
► Medboard platform: https://www.medboard.com/ ► Podcast page: https: //podcast.easymedicaldevice.com/226-2/ ► MEDBOARD SHOW NOTES LINKS: https://www.medboard.com/reports/easy-medical-device-regulatory-update/2023/april/ Today on this Medical Device news for March 2023 we’ll talk about • The EU […] The post Medical Device News – March 2023 Regulatory Update appeared first on Medical Device made Easy Podcast . hamza benafqir...
In this episode, Bijan Elahi will help us perform risk management for SaMD and give us some tips on the best strategies. Bijan is also the author of the book […] The post How to perform Risk Management for a Software ? appeared first on Medical Device made Easy Podcast . hamza benafqir
The postmarketing surveillance is a major process within the EU MDR. Today Marcus Emne from Hoodin will explain to us how this is working and how the Artificial intelligence may help. The post How to create a Proactive Postmarketing Surveillance? [EU MDR] appeared first on Medical Device made Easy Podcast . hamza benafqir...
Vigilance Reporting is one of the process that everyone should have but that no one wants to use. So this is really difficult to understand all the requirements to it. Also knowing that this may change from one coutry to another. The post What you should know about Vigilance Reporting for Medical Devices? appeared first on Medical Device made Easy Podcast . hamza benafqir...
A lot of information within this update. So check the show notes as this may be a bit too much for you. This March Update is going through Europe but also US, Middle East, South Africa. A world tour. lol The post Medical Device News: March 2023 Regulatory Update appeared first on Medical Device made Easy Podcast . hamza benafqir...
In this episode, Tautvydas will share with us its experience with Manufacturers that tries to move from Class I to Class Ir for Reusable Surgical Instruments. Don't miss it if your company is on scope. The post Prepare your transition from Class I to Class Ir appeared first on Medical Device made Easy Podcast . hamza benafqir...
