Medical Device made Easy Podcast

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