Medical Device made Easy Podcast

Dec 11 2024 323 ep. 35 mins 51
Medical Device made Easy Podcast artwork

My name is Monir El Azzouzi and I am a Medical Device Expert specialized in Quality and Regulatory affairs. And on this podcast I will help you place compliant medical devices on the market. For that I will share with you my knowledge or the one of others through discussion or interviews. I will invite experts in the area to tell you what you can do or the challenges you may encounter.

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Medical Device News december 2024 Regulatory Update

Dec 11 2024 31 mins  
MEDBOARD: https://www.medboard.com/ EUROPE TEAM-NB high level position - Making Medical Devices Safer and Faster: https://www.team-nb.org/wp-content/uploads/2024/12/Team-NB-HighLevel-Strategy- PositionPaper-20241130.pdf - MDCG 2024-15 - Reporting Medical Device Trials Made Easy!: https://health.ec.europa.eu/document/download/0e076d19-62dc-4ff9-83f2-be6072a45993_en? filename=mdc

PCCP – The Magic tool for SaMD in the US?

Dec 04 2024
In this episode, Maria Diez from CMGMedDev is explaining to us the PCCP tool for SaMD and why it can help a lot. We will also review US vs EU regarding changes to SaMD. Who is Maria Diez? María Diez is a seasoned expert in Quality Assurance (QA) and Regulatory Affairs (RA) for medical devices and in vitro diagnostic devices (IVDs), with over a decade of professional experience i

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

Nov 27 2024 32 mins  
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. Who is Beat Keller? Beat Keller is the founder and Managing Director of SMDC which supports medical devices to bring compliant medical devices on market quickly. Next to his experience in the medical device industry first as

How to build the perfect Quality Management System?

Nov 20 2024 37 mins  
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. Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulat

Is FMEA bad for your Risk Management? 

Nov 13 2024 30 mins  
In this episode, Rod Beuzeval will explain the reason why FMEA is maybe not the right method for your Risk Management per ISO 14971. So, check this and tell us if you agree. Who is Rod Beuzeval? Rod has 25+ years of experience in the medical device and pharmaceutical industry. He has expertise in regulatory strategy, technical documentation, QMS systems, standards compliance,

How MDR and IVDR code can save you money?

Nov 06 2024 35 mins  
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. Who is Stefan Bolleininger? Stefan Bolleininger is a key opinion leader and speaker for the medical device regulation MDR in Europe. He founded the be-on-Quality GmbH consulting agency to passionat

Medical Device News November 2024 Regulatory Update

Oct 30 2024 23 mins  
Medboard https://www.medboard.com/ EU Urgent update needed - EU MDR and IVDR: https://www.europarl.europa.eu/doceo/document/TA-10-2024-0028_EN.pdf HMA communication: https://www.hma.eu/fileadmin/dateien/Medical_Devices/CGMD/241018_Letter.pdf EU Commission Newsletter - What are the hot news: https://ec.europa.eu/newsroom/sante/newsletter-archives/56793 MDCG 2021-25 ;legacy devices &

What does a strategy for regulatory compliance looks like?

Oct 23 2024 31 mins  
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. Who is Adam Isaacs Rar? Chartered quality professional with a Master’s Degree focused in Strategic Quality Management from University of Portsmouth. Demonstrated history o

What are the TOP 3 issues on CAPAs? 

Oct 16 2024 47 mins  
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. Who is Georg Digel? I've reviewed too many Medical Device CAPAs over the last 10 years. I think I've seen almost every mistake there is ...Some

Medical Device News, october 2024 Regulatory Update

Oct 09 2024 22 mins  
Medboard: https://www.medboard.com/ EUROPE TEAM NB - Code of Conduct for NB - Version 5: https://www.team-nb.org/wp-content/uploads/2024/09/PressRelease-CoC-20240916.pdf TEAM NB - IVDR Transition - Transition to the implementation of Class D oversight by EURLs: https://www.team-nb.org/wp-content/uploads/2024/10/PressRelease-ClassD-20241001.pdf Title: MDCG 2021-4 Rev 1 update-