Medical Device made Easy Podcast Archiv
417 Episoden
1 Minute
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
The post Prepare your audit like a PRO appeared first on Medical Device made Easy Podcast. hamza benafqir
1 Minute
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
The post What is a SOUP for your Software Development? appeared first on Medical Device made Easy Podcast. hamza benafqir
1 Minute
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
The post Medical Device News – March 2023 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir
1 Minute
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 post How to perform Risk Management for a Software ? appeared first on Medical Device made Easy Podcast. hamza benafqir
![How to create a Proactive Postmarketing Surveillance? [EU MDR]](https://cdn.podcastcms.de/images/shows/175/983314/s/665083584/how-to-create-a-proactive-postmarketing-surveillance-eu-mdr.png)
1 Minute
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
The post How to create a Proactive Postmarketing Surveillance? [EU MDR] appeared first on Medical Device made Easy Podcast. hamza benafqir
1 Minute
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
The post What you should know about Vigilance Reporting for Medical Devices? appeared first on Medical Device made Easy Podcast. hamza benafqir
1 Minute
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
The post Medical Device News: March 2023 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir
1 Minute
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
The post Prepare your transition from Class I to Class Ir appeared first on Medical Device made Easy Podcast. hamza benafqir
1 Minute
The Global reach can be a problem when we talk about Medical Device. This is mainly what we will discuss with Stéphane Berger as he is trying to put globally is Software as a Medical Device in different markets. Let'S hear about the difficulty.
The post SaMD international reach – What to consider? appeared first on Medical Device made Easy Podcast. hamza benafqir
The post SaMD international reach – What to consider? appeared first on Medical Device made Easy Podcast. hamza benafqir
1 Minute
If you need to perform a Biological Evaluation for your Medical Device, Paul and Laura from Icare Group will be the best partners for you. Check the advice they provide.
The post Biological Evaluation: Top Big mistakes appeared first on Medical Device made Easy Podcast. hamza benafqir
The post Biological Evaluation: Top Big mistakes appeared first on Medical Device made Easy Podcast. hamza benafqir
1 Minute
Your Medical Device News is ready for the month of February 2023. This is containing some information on the extension of the EU MDR timeline so don't miss it.
The post Medical Device News: February 2023 Regulatory Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
The post Medical Device News: February 2023 Regulatory Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
Post marketing Surveillance for medical devices in the US market is done differently than in EU. So learn on this podcast how to be prepared with Rob Packard. We will talk about multiple sort of devices and how FDA is handling the way to do Post Marketing Surveillance so if you are selling to the US market, check this.
The post How to do Post-Marketing Surveillance in the US (vs EU)? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
The post How to do Post-Marketing Surveillance in the US (vs EU)? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
You maybe arrived to this section of the Techniocal File asking for Risk Benefit Ratio and you don't know what to write on it. On this episode we will explain to you what are your possibilities and how you should thing about Risk-Benefit ratio with Naveen Agarwal.
The post How to evaluate Benefit-Risk Ratio for Medical Devices? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
The post How to evaluate Benefit-Risk Ratio for Medical Devices? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
You asked for the extension of the transition period for MDR? Then you have the proposal for the change. Now the question is if you are satisfied and if the content is helping you? No worry if you don't like it they are expecting your immediate comment as tomorrow is the last day.
The post Breaking News: EU MDR Extension Proposal is out for consultation appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
The post Breaking News: EU MDR Extension Proposal is out for consultation appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
Let's see if you can improve relationship between your industry departments and Quality and Regulatory affairs. We will talk about that with Omar M. Khateeb who will explain to us how Marketing and QA RA should work together.
The post How to improve the relationship between QA – RA and Marketing? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
The post How to improve the relationship between QA – RA and Marketing? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
