Medical Device made Easy Podcast

Cybersecurity in Medical Devices – A QA/RA Perspective Cybersecurity is often seen as an IT or engineering issue—but in reality, regulators and auditors turn to QA and Regulatory Affairs professionals […] The post Cybersecurity in Medical Devices – What QA/RA Must Do Today appeared first on Medical Device made Easy Podcast. hamza benafqir

Medboard EUROPE UK Switzerland Magazine Podcast: REST OF THE WORLD The post Medical Device News September 2025 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir

Artificial Intelligence is no longer just a buzzword — it’s already finding its way into Quality Assurance (QA) and Regulatory Affairs (RA) in the medical device industry. But what does […] The post The good, bad and uglyof using AIfor QA RA Compliance appeared first on Medical Device made Easy Podcast. hamza benafqir

Managing Software Updates in Medical Devices: Best Practices & Pitfalls In the world of medical devices, software updates are never just technical tweaks—they directly impact patient safety, regulatory compliance, and […] The post Medical Device Software Versioning appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

From Zero to One: Mastering Client Collaboration in ConsultingStarting your consulting journey can feel overwhelming—finding clients, building trust, and delivering results all at once. In my conversation for the Medical […] The post From Zero to One How to collaborate with clients appeared first on Medical Device made Easy Podcast. hamza benafqir

Have you ever wondered what it’s really like to work as a medical device consultant or ISO 13485 auditor? In this episode of the Medical Device Made Easy Podcast, I […] The post From Zero to One: Becoming a Medical Device auditor appeared first on Medical Device made Easy Podcast. hamza benafqir

In our latest podcast, we dive deep into the recruitment world with Mitch, a founder and specialist recruiter in Quality Assurance & Regulatory Affairs (QA/RA). If you’re a hiring manager, […] The post From Zero to One – Should You Work with a QA/RA Recruiter? | Podcast Episode appeared first on Medical Device made Easy Podcast. hamza benafqir

Everything You Need to Know About EU Regulation 2025/1234 and the Future of eIFU for Medical Devices On July 16, 2025, a pivotal regulatory update—EU 2025/1234—comes into effect, expanding the […] The post Why Switch to eIFU? Top Regulatory & Operational Benefits Explained for Medical Device Manufacturers appeared first on Medical Device made Easy Podcast. hamza benafqir

Quality & Regulatory in MedTech – Interview with Pardeep Kaur  Background: From IT in India to MedTech in Norway  Day-to-Day as a QARA Manager   First MedTech Role at Hy5Pro AS  […] The post Quality & Regulatory in MedTech – Interview with Pardeep Kaur appeared first on Medical Device made Easy Podcast. hamza benafqir

Guest: Stefan Bolleininger  Title: From Zero to One: Creating your Consulting Firm  Logo: Be on Quality   Telling the story behind Be on Quality,   Sharing also the life of a CEO […] The post From Zero to One: Creating your Consulting Firm appeared first on Medical Device made Easy Podcast. hamza benafqir

Medboard: https://www.medboard.com/ EUROPE UK ROW Podcast The post Medical Device News JULY 2025 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir

From Zero to One: SaaS Founder’s First Five Years with Ivan Perez Chamorro 🎧💡 In this exciting episode of the Easy Medical Device Podcast, we welcome Ivan Perez Chamorro, the […] The post From Zero to One: SaaS Founder’s First Five Years appeared first on Medical Device made Easy Podcast. hamza benafqir

🎙️ Risk Grading Gone Wrong: How to Fix Your Severity, Occurrence & Detection Strategy Before Your Notified Body Does 🩺 Risk Management mistakes that could cost you your certification! In […] The post Notified Bodies raise concern on Risk Grading appeared first on Medical Device made Easy Podcast. hamza benafqir

In this episode, Anindya Mookerjea will share with us his knowledge on Software Testing. We will review the basics and help you with being compliant to your projects. The post Software as a Medical Device: Beginner’s Guide to Testing & Validation appeared first on Medical Device made Easy Podcast. hamza benafqir

episode 339 Medical Device News JUNE 2025 Regulatory Update monir el azzouzi easy medical device The post Medical Device News JUNE 2025 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir

Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson […] The post Trapped or Strategic? Changing Notified Bodies During MDR Transition appeared first on Medical Device made Easy Podcast. hamza benafqir

In this episode, Carmen Bellebna will share with us the journey of deepeye Medical to implement the EU AI act requirements in parallel with the EU MDR certification. The post How deepeye Medical overcame the AI ACT? appeared first on Medical Device made Easy Podcast. hamza benafqir

In this episode, Cecile van der Heijden will disclose all the secret of the EHDS or European Health Data Space law. The post Is EHDS dangerous for Medical Device manufacturers? appeared first on Medical Device made Easy Podcast. hamza benafqir

In this episode, Aouda Ouzza is helping us understand when the Regulatory Affairs person is needed during the design phase. The post When is Regulatory Affairs needed during Design? appeared first on Medical Device made Easy Podcast. hamza benafqir

In this episode, Claire Dyson will clarify to us what is the new PMS requirements from UK MHRA. The post What is the new UK Post-Market Surveillance Requirements? appeared first on Medical Device made Easy Podcast. hamza benafqir

In this episode, Adam Isaacs Rae is helping us to register our Medical Devices in Malaysia. We will review the requirements for it. The post How to register your Medical Device in Malaysia? appeared first on Medical Device made Easy Podcast. hamza benafqir

In this episode, Yassine Bader will explain to you the advantage or the risk of quitting your permanent job to become a consultant. The post Should you quit your job to become a consultant? appeared first on Medical Device made Easy Podcast. hamza benafqir

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

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

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

Medical Device News January 2025 Regulatory Update The post Medical Device News March 2025 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir

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

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

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

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

Medboard EU Training Rest of the World: Podcast The post Medical Device News January 2025 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir

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

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

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

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

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

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

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

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

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

: 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

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

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

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

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

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

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

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

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

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