PODCAST

Medical Device made Easy Podcast

Monir El Azzouzi

Listen Medical Device Regulation and Standards

business management & marketing

All Episodes

Automatisation of your QA RA job with AI

Medical Device made Easy Podcast ·

2025/11/05

Artificial Intelligence is reshaping the world of Quality and Regulatory Affairs.In this podcast episode, Hatem Rabeh joins to demystify how AI can be used — and where it must be […]The post Automatisation of your QA RA job with AI appeared first on Medical Device made Easy Podcast. hamza benafqir

en-US

Clinical Evidence under EU MDR – Why So Many Dossiers...

Medical Device made Easy Podcast ·

2025/10/16

Since the implementation of EU MDR 2017/745, clinical evidence has become one of the biggest challenges for medical device manufacturers — and a major source of Notified Body nonconformities. This […]The post Clinical Evidence under EU MDR – Why So Many Dossiers Fail (and How to Fix It) appeared first on Medical Device made Easy Podcast. hamza benafqir

en-US

From Surgeon to CEO: Building NEUROGYN AG Professor...

Medical Device made Easy Podcast ·

2025/09/18

The journey from a successful surgical career to the leadership of a medical company is far from ordinary. Yet for Prof. Marc Possover, this evolution felt like a natural extension […]The post From Surgeon to CEO: Building NEUROGYN AG Professor Marc Possover’s Journey appeared first on Medical Device made Easy Podcast. hamza benafqir

en-US

The good, bad and uglyof using AIfor QA RA Compliance

Medical Device made Easy Podcast ·

2025/08/28

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

en-US

From Zero to One How to collaborate with clients

Medical Device made Easy Podcast ·

2025/08/14

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

en-US

From Zero to One – Should You Work with a QA/RA...

Medical Device made Easy Podcast ·

2025/07/31

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

en-US

Medical Device News JULY 2025 Regulatory Update

Medical Device made Easy Podcast ·

2025/07/03

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

en-US

From Zero to One: SaaS Founder’s First Five Years

Medical Device made Easy Podcast ·

2025/06/25

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

en-US

Notified Bodies raise concern on Risk Grading

Medical Device made Easy Podcast ·

2025/06/18

🎙️ 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

en-US

Software as a Medical Device: Beginner’s Guide to...

Medical Device made Easy Podcast ·

2025/06/12

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

en-US

Medical Device News JUNE 2025 Regulatory Update

Medical Device made Easy Podcast ·

2025/06/04

episode 339 Medical DeviceNews 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

en-US

Trapped or Strategic? Changing Notified Bodies During...

Medical Device made Easy Podcast ·

2025/05/28

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

en-US

Is EHDS dangerous for Medical Device manufacturers?

Medical Device made Easy Podcast ·

2025/05/15

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

en-US

When is Regulatory Affairs needed during Design?

Medical Device made Easy Podcast ·

2025/05/07

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

en-US

How to register your Medical Device in Malaysia?

Medical Device made Easy Podcast ·

2025/04/24

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

en-US

What if the Notified Body asks you: Is your Software...

Medical Device made Easy Podcast ·

2025/03/27

In this episode, Tibor Zechmeister will challenge us on what we would answer if the Notified Body asks if our software is validated. CSV or Computer System Validation will become one of the major topics The post What if the Notified Body asks you: Is your Software Validated? appeared first on Medical Device made Easy Podcast. hamza benafqir

en-US

What are the TOP 3 FDA inspection issues?

Medical Device made Easy Podcast ·

2025/03/20

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

en-US

How to avoid Clinical Investigation for your Device?

Medical Device made Easy Podcast ·

2025/03/06

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 InvestigationsThe post How to avoid Clinical Investigation for your Device? appeared first on Medical Device made Easy Podcast. hamza benafqir

en-US

How and Who to build your Risk Management File?

Medical Device made Easy Podcast ·

2025/02/20

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

en-US

The good, the bad and the ugly of certification bodies

Medical Device made Easy Podcast ·

2025/02/13

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

en-US

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Medical Device made Easy Podcast

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