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Episodes

How to satisfy Cybersecurity for FDA and EU?

In this episode, Cyrille Michaud from MD101 will explain us how to prepare for Cybersecurity compliance for your medical device. The post How to satisfy Cybersecurity for FDA and EU? appeared first on Medical Device made Easy Podcast . hamza benafqir

Apr 10, 2025

Medical Device News April 2025 Regulatory Update

Sponsor: Medboard Europe Registration ROW Podcast Social Media to follow The post Medical Device News April 2025 Regulatory Update appeared first on Medical Device made Easy Podcast . hamza benafqir

Apr 04, 2025

What are the TOP 3 FDA inspection issues?

In this episode, Darrin Carlson will explain to us what are the main issues that are discovered during FDA inspections and how to correct them. The post What are the TOP 3 FDA inspection issues? appeared first on Medical Device made Easy Podcast . hamza benafqir

Mar 20, 2025

How to avoid Clinical Investigation for your Device?

In this episode, Hatem Rabeh will explain to us what are Clinical Data and also if there is a chance for you to avoid Clinical Investigations The post How to avoid Clinical Investigation for your Device? appeared first on Medical Device made Easy Podcast . hamza benafqir

Mar 06, 2025

FDA: Advantage of the Breakthrough Device Program

In this episode, Michelle Lott will walk us through the Breakthrough Device Program created by the FDA. Who can benefit from it? And what are the benefits? The post FDA: Advantage of the Breakthrough Device Program appeared first on Medical Device made Easy Podcast . hamza benafqir

Feb 27, 2025

How and Who to build your Risk Management File?

In this episode, Bijan Elahi will share with us the methodology you should follow to start your Risk Management Project The post How and Who to build your Risk Management File? appeared first on Medical Device made Easy Podcast . hamza benafqir

Feb 20, 2025

The good, the bad and the ugly of certification bodies

In this episode, Mark Rogovoi will share his experience with Certification Bodies. The post The good, the bad and the ugly of certification bodies appeared first on Medical Device made Easy Podcast . hamza benafqir

Feb 13, 2025

6 Tips to Grow as a QA RA Manager

In this episode, I will give you some advice on how to grow as a QA RA Manager. The post 6 Tips to Grow as a QA RA Manager appeared first on Medical Device made Easy Podcast . hamza benafqir

Jan 30, 2025

TOP 5 common NCs on an ISO 13485 audit

In this episode, Adam Isaac Rae will share with us is TOP 5 common NCs during an ISO 13485 audit. The post TOP 5 common NCs on an ISO 13485 audit appeared first on Medical Device made Easy Podcast . hamza benafqir

Jan 23, 2025

How to perform your PMS for a Drug-Device Combination?

In this episode, Dr. Joan D’Souza will help us to do our PMS the right way when we have to deal with a Drug-Device Combination. The post How to perform your PMS for a Drug-Device Combination? appeared first on Medical Device made Easy Podcast . hamza benafqir

Jan 16, 2025

How to register a Medical Device in South Africa?

In this episode, Khanyisile Nkuku will share with us the way companies can register an medical device in South Africa. The post How to register a Medical Device in South Africa? appeared first on Medical Device made Easy Podcast . hamza benafqir

Jan 09, 2025

Medica: AI & MDR FLIP THE COIN

Stefan bolleininger will share with us information regarding Artificial intelligence and MDR. This presentation happened during Medica 2024. So if you have any questions you can ask ok the comments. […] The post Medica: AI & MDR FLIP THE COIN appeared first on Medical Device made Easy Podcast . hamza benafqir...

Jan 02, 2025

Easy Medical Device Great Summary 2024

In this episode, Monir El Azzouzi will summarize 2024 for Easy Medical Device and share projects for 2025. The post Easy Medical Device Great Summary 2024 appeared first on Medical Device made Easy Podcast . hamza benafqir

Dec 26, 2024

What are the major pitfalls of Startups in Medical Devices?

In this episode, Adnan Ashfaq will share with us the major pitfalls he experienced when dealing with Medical Device startups. The post What are the major pitfalls of Startups in Medical Devices? appeared first on Medical Device made Easy Podcast . hamza benafqir

Dec 19, 2024

Medical Device News December 2024 Regulatory Update

MEDBOARD: https://www.medboard.com/ EUROPE SMARTEYE EVENTS TRAINING ROW • Webinar January 14, 2025 – https://www.fda.gov/medical-devices/cdrhnew-news-andupdates/webinar-final-guidance-marketing-submission-recommendations-predetermined-change-control-plan?utm_source=FDALinkedin PODCAST Social Media to follow The post Medical Device News December 2024 Regulatory Update appeared first on Medical Device made Easy Podcast . hamza benafqir...

Dec 12, 2024

PCCP – The Magic tool for SaMD in the US?

In this episode, Maria Diez from CMGMedDev is explaining to us the PCCP tool for SaMD and why it can help a lot. The post PCCP – The Magic tool for SaMD in the US? appeared first on Medical Device made Easy Podcast . hamza benafqir

Dec 05, 2024

IEC 60601-1-8 How to test your Medical Device alarms?

: In this episode, Beat Keller from SMDC in Switzerland will help us to setup the right tests for your alarm systems. And you’ll see that it is not so obvious. The post IEC 60601-1-8 How to test your Medical Device alarms? appeared first on Medical Device made Easy Podcast . hamza benafqir

Nov 28, 2024

How to build the perfect Quality Management System?

In this episode, Monir El Azzouzi will help you build the perfect Quality Management System. He will give you his recipe to start the creation of a QMS and show you step by step what you should do. The post How to build the perfect Quality Management System? appeared first on Medical Device made Easy Podcast . hamza benafqir...

Nov 21, 2024

Is FMEA bad for your Risk Management?

Podcast: Is FMEA bad for your Risk Management? With Monir El Azzouzi and Rod Beuzeval The post Is FMEA bad for your Risk Management? appeared first on Medical Device made Easy Podcast . hamza benafqir

Nov 14, 2024

How MDR and IVDR code can save you money?

In this episode, Stefan Bolleininger will explain you can save money on your MDR or IVDR submission just by choosing the right MDR or IVDR code and by following some of his advice. The post How MDR and IVDR code can save you money? appeared first on Medical Device made Easy Podcast . hamza benafqir

Nov 07, 2024

Medical Device News November 2024 Regulatory Update

Medboard https://www.medboard.com/   EU   Training   Events MedtechConf events – Check the MAP   ROW Australia Mexico GMP for Mexico – Draft document: https://www.dof.gob.mx/nota_detalle.php?codigo=5734591&fecha=26/07/2024#gsc.tab=0   South Africa   PODCAST […] The post Medical Device News November 2024 Regulatory Update appeared first on Medical Device made Easy Podcast . hamza benafqir...

Oct 31, 2024

What does a strategy for regulatory compliance looks like?

In this episode, Adam Isaacs Rae will help us shape your Regulatory Compliance Strategy. This is a requirement of the EU MDR and IVDR but it doesn’t provide much information. So let’s review that together. The post What does a strategy for regulatory compliance looks like? appeared first on Medical Device made Easy Podcast . hamza benafqir...

Oct 24, 2024

What are the TOP 3 issues on CAPAs?

In this episode, Georg Digel will help use solve 3 major problems with our CAPAs. He will tell you what these problems within your Quality Management System are and propose some solution. We will also talk about the education of the team. The post What are the TOP 3 issues on CAPAs? appeared first on Medical Device made Easy Podcast . hamza benafqir...

Oct 17, 2024

Medical Device News, October 2024 Regulatory Update

Medboard: https://www.medboard.com/ EUROPE EVENTS NB ROW Middle East Northern America South America: PODCAST Social Media to follow The post Medical Device News, October 2024 Regulatory Update appeared first on Medical Device made Easy Podcast . hamza benafqir

Oct 10, 2024

How to select the best plastic for your Medical Device?

In this episode, Lucas Pianegonda will help us to select the right material for your medical device and answer questions that you maybe would love to hear his answer. We will also talk about sustainability for plastics. So, check this. The post How to select the best plastic for your Medical Device? appeared first on Medical Device made Easy Podcast . hamza benafqir...

Oct 03, 2024

UK vs EU vs US – How to switch to another region easily?

In this episode, Claire Dyson will give us the recipe to launch correctly your Medical Device when you go abroad and for that we will take the example of EU and US. The post UK vs EU vs US – How to switch to another region easily? appeared first on Medical Device made Easy Podcast . hamza benafqir

Sep 24, 2024

How to do a PMCF Literature Search for Medical Devices?

In this episode, Cesare Magri will try to improve our skills on PMCF literature search. We will investigate on the misconceptions and what people should make to do it right. The post How to do a PMCF Literature Search for Medical Devices? appeared first on Medical Device made Easy Podcast . hamza benafqir...

Sep 17, 2024

Medical Device News, Septembre 2024 Regulatory Update

EU Switzerland Training Events: ROW Medical Device Live Expert: Podcast The post Medical Device News, Septembre 2024 Regulatory Update appeared first on Medical Device made Easy Podcast . hamza benafqir

Sep 10, 2024