Medical Device made Easy Podcast Archiv
417 Episoden
1 Minute
In this episode, Beat Keller from imt will be helping us to understand the secrets of Predicate Devices. This is specific to the US Market, but we will also make few parallels with the EU as we have also the possibility to use equivalent device within the EU MDR. But is it the same?
The post How to find your Predicate Device for your 510K Submission? appeared first on Medical Device made Easy Podcast. hamza benafqir
The post How to find your Predicate Device for your 510K Submission? appeared first on Medical Device made Easy Podcast. hamza benafqir
1 Minute
In this episode, Cesare Magri will help us understand how API can be considered as a Medical Device. Some calculators are existing and also used as API. So should those API developers create a QMS and Technical File for their product? How can you prove your API is safe and performant? Check answers on this episode
The post How to CE certify a Calculator, Risk Score…? appeared first on Medical Device made Easy Podcast. hamza benafqir
The post How to CE certify a Calculator, Risk Score…? appeared first on Medical Device made Easy Podcast. hamza benafqir
1 Minute
This episode will be your Update of what happened within the Medical Device community. Check the show notes for all the links. Use these updates also for your QMS Regulatory updates so don’t hesitate to make your own assessment.
The post Medical Device News – November 2023 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir
The post Medical Device News – November 2023 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir
1 Minute
MDCG 2023-4 was released and this raised a lot of questions or concerns. If you are using a software and for the functioning of it you need sensors or cameras from a third party device like a smartphone, then who is responsible to validate this third party device?
The post Validate your Iphone, Samsung Galaxy, Huawei… for your Software appeared first on Medical Device made Easy Podcast. hamza benafqir
The post Validate your Iphone, Samsung Galaxy, Huawei… for your Software appeared first on Medical Device made Easy Podcast. hamza benafqir
1 Minute
This is part 2 of the interviews made at Afrisummit. I was able to interview some key stakeholders. I am sharing with you these interviews and I hope this will help you understand the situation in Middle East and Africa.
The post Afrisummit 2023 Interviews Part 2 – Egypt Situation appeared first on Medical Device made Easy Podcast. hamza benafqir
The post Afrisummit 2023 Interviews Part 2 – Egypt Situation appeared first on Medical Device made Easy Podcast. hamza benafqir
1 Minute
When I was at the Afrisummit I was able to interview some key stakeholders. I am sharing with you these interviews and I hope this will help you understand the situation in Middle East and Africa.
The post Afrisummit 2023 Interviews Part 1 appeared first on Medical Device made Easy Podcast. hamza benafqir
The post Afrisummit 2023 Interviews Part 1 appeared first on Medical Device made Easy Podcast. hamza benafqir
1 Minute
When we develop a Software, there are some pitfalls that you can avoid. Weronika Michaluk from HTD Health will explain to us how to do that. Don’t miss this to accelerate your development and avoid to redo some activities.
The post What are some pitfalls to avoid during Software Design? appeared first on Medical Device made Easy Podcast. hamza benafqir
The post What are some pitfalls to avoid during Software Design? appeared first on Medical Device made Easy Podcast. hamza benafqir
1 Minute
MEDICAL DEVICE NEWS October 2023 Regulatory Update
The post October 2023 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir
The post October 2023 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir
1 Minute
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
The post What is the EUDAMED Updates? appeared first on Medical Device made Easy Podcast. hamza benafqir
1 Minute
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
The post Interviews on Being The PRRC (Part 2) appeared first on Medical Device made Easy Podcast. hamza benafqir
1 Minute
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
The post MEDICAL DEVICE NEWS – SEPTEMBER 2023 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir
1 Minute
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
The post How to perform your Cleaning Validation in practice? appeared first on Medical Device made Easy Podcast. hamza benafqir
1 Minute
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
The post What are the Acceptance Criteria for your Clinical Evaluation? appeared first on Medical Device made Easy Podcast. hamza benafqir
1 Minute
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
The post Why you should automate your Software validation? appeared first on Medical Device made Easy Podcast. hamza benafqir
1 Minute
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
The post Hire your QA RA person with no Budget appeared first on Medical Device made Easy Podcast. hamza benafqir
