Medical Device made Easy Podcast

May 12 2024 47
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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How to select and evaluate your Contract Manufacturer? 

May 12 2024 31 mins  
Medical Device manufacturers can also involve third party companies to manufacture their devices. We call them Contract Manufacturers. But they are only your supplier and not the legal manufacturer of the product. So now the question is how to select them and also how to handle them. Let’s find that out with Keith Smith from Vonco Who is Keith Smith? Keith Smith is the Presi

Quality Field Service for Medical Devices?

May 06 2024 30 mins  
Michael Israel from Zuper.co is helping us understand the world of Field Service and then we can understand better how some information collected by Field Service Engineer can help Quality Department to have a better operation. Collect machine performance, train technicians, identify issues. Michael will also talk about Zuper which is a FSM software (Field Service Management) an

Medical Device NewsMAY 2024 Regulatory Update

May 02 2024 37 mins  
EU Notified Bodies TUV SUD Denmark under MDR –Welcome to the Brother or Sister: https://api.tech.ec.europa.eu/nando-prod/files?repo=nando&id=150a0abbc0d4397086d648963fc940a321e02c11&group=NOTIFICATION&download=true AFNOR 46th NB under MDR –Finally a second one for France: https://webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies/notifications?org

Why and how to build a Quality Culture?

Apr 22 2024 37 mins  
A quality culture seem to be a nice to have. But after listening this podcast episode with Lesley Worthington, you will see that it is worth to build one. We will review the description of a quality culture and how to build it. But also if this is required by a regulation and how you can align it with your compliance duties. Check this and share it with your team. Who is Lesley

What is the impact of AI Act on Medical Devices? 

Apr 15 2024 43 mins  
The AI Act or Artificial Intelligence Act is now a reality. But what does it mean for the Medical Device industry and what should you do within your Quality or Regulatory affairs activities. Erik Vollebregt, from Axon Lawyers will tell us what we should understand with this new legislation and what are the consequences for the Medical Device community. Who is Erik Vollebregt?

Radiation Sterilisation Master File (ISO 11137 & 11607) 

Apr 08 2024 37 mins  
If your products need to be sterilized, then you will need to prove that the sterilization process is validated and continues to work all through the life to the product. So Adam Isaacs Rae will provide you with the information on Radiation Sterilization requirements. Standards, guidelines, pitfalls. All this will help you remain compliant. Who is Adam Isaacs Rae? Chartered qu

Medical Device News April 2024 Regulatory Update

Apr 03 2024 31 mins  
Sponsor: Medboard: https://www.medboard.com/ EU MDR and IVDR national languages update - France accepts English MDR: https://health.ec.europa.eu/document/download/aa9760e3-c864-4173-8b16-d790dac66d74_en?filename=md_sector_lang-req-table-mdr.pdf IVDR: https://health.ec.europa.eu/document/download/1e312d8f-8b34-45da-a5fa-1918ba618aca_en?filename=md_sector_lang-req-table-ivdr.pd

ow to benefit from Surveys to build Clinical Evidence?

Mar 25 2024 33 mins  
Since EU MDR and IVDR launched, there is a phenomenon that raised which is the use of surveys to gather clinical data. So we wanted to share with you how to do this right and what you should be careful on. So listen to Cesare Magri from 4BetterDevices who will tell us more about surveys in the Medical Device field. Who is Cesare Magri? Cesare has a mixed Background: Physics an

How to do Postmarketing Surveillance the right way? 

Mar 18 2024 31 mins  
The EU MDR and IVDR is a bit more demanding on Postmarketing Surveillance. In this episode we will explain to you from the eye of an auditor what they want to see and how you can avoid some mistakes that are always identified. Who is Steve Curran? Dr Steve Curran has over 20 years experience in the medical device industry both as an engineer and leader developing medical devic

FDA aligns QMSR with ISO 13485? 

Mar 11 2024 33 mins  
The FDA announced the alignment of QMSR to the ISO 13485 standard. So now the question is: What does it change for me? Do you need to update your full QMS? Will you need to go through another audit or inspection? Is this really a revolution? Naveen Agarwal from Exceed will answer this question. So don’t miss this episode to know more about QMSR. Who is Naveen Agarwal? Dr. Nave