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Medical Device made Easy Podcast Archiv

417 Episoden

How to implement Vigilance Reporting for MDR and IVDR?

1 Minute
Vigilance Reporting is an important system to have within your quality management system. Even if you are still MDD, you need to comply to the MDR requirements for it. So I will help you for that.

The post How to implement Vigilance Reporting for MDR and IVDR? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

System and Procedure Pack the RETURN with Erik Vollebregt

1 Minute
After receiving a lot of questions on System and Procedure pack we have decided to have a second episode on it with Erik Vollebregt. So let's review some special cases and also some feedback from the authorities.

The post System and Procedure Pack the RETURN with Erik Vollebregt appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

How to interpret the first Expert Panel Opinion? [Bassil Akra]

1 Minute
Bassil Akra will help use interpret this first Expert Panel Opinion. Bassil already helped on a previous episode where we discussed about the creation of this Expert Panel. Let's review this first outcome and see the consequence of it for the industry.

The post How to interpret the first Expert Panel Opinion? [Bassil Akra] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

Medical Device News: The July 2021 Update [MDR IVDR FDA SFDA]

1 Minute
We will update you on all what happened within the Medical Device regulation. All new

The post Medical Device News: The July 2021 Update [MDR IVDR FDA SFDA] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

How to build your State-of-the-art for your Medical Devices?

1 Minute
The State-of-the Art is one of the component that can make you win or make you lose. If this research is not done correctly, it can ruin your Clinical Evaluation Report or Performance Evaluation Report. Hakan Inan from Requalite will explain to us why this is important.

The post How to build your State-of-the-art for your Medical Devices? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

How Intellectual Property is linked to the Medical Device Regulation?

1 Minute
In the case you are placing your brand trademark on a product, or if you buy a product designed by another company... then you need to understand the rules related to Intellectual properties. This episode with Stephen Carter will be a masterclass about Intellectual Property.

The post How Intellectual Property is linked to the Medical Device Regulation? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

How to perform a good Clinical Investigation with Helene Quie

1 Minute
Clinical Investigation is not really an easy process. So it can be important for your to understand what are the requirements and get some details about time and cost. Helene Quie from Qmed Consulting which is also a CRO will help us learn more about this process required by EU MDR.

The post How to perform a good Clinical Investigation with Helene Quie appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

How to perform a Biological Evaluation for your Medical Device?

1 Minute
This podcast episode is really important as this answers some of the questions that a lot of my customers are asking. So I hope this will help you to understand why this is important to perform a Biological Evaluation or Biocompatibility for your finished product.

The post How to perform a Biological Evaluation for your Medical Device? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

Medical Device News – June 2021 Update [EU MDR Date of Application]

1 Minute
Medical Device News June 2021 Update is providing you all the last updates. This IS the episode of the EU MDR date of application. A lot of news provided.

The post Medical Device News – June 2021 Update [EU MDR Date of Application] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

EU MDR Survey: What is the Industry’s opinion? [Catherine Higginson]

1 Minute
EU MDR is starting tomorrow and we wanted to check the situation for Economic Operators. We had already interviewed Catherine on the previous survey release. This time we do a follow-up

The post EU MDR Survey: What is the Industry’s opinion? [Catherine Higginson] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

MDR is coming so brace yourself with Erik Vollebregt

1 Minute
1 week to the EU MDR and we hope that you are ready. If not, then you can maybe listen to this episode as we are answering some last minute questions.

The post MDR is coming so brace yourself with Erik Vollebregt appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

FDA: Is the Emergency Use Authorization worth it? (EUA)

1 Minute
This process called EUA was really famous last year when everyone wanted to register its face mask or respirator or covid-19 test in the USA. After 1 year let's see the conclusion of Michelle Lott on it.

The post FDA: Is the Emergency Use Authorization worth it? (EUA) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

Medical Device News – May 2021 Update [EU MDR 2017/745]

1 Minute
This is the last month before the EU MDR 2017/745 Date of Application. We will talk about that and about all the updates

The post Medical Device News – May 2021 Update [EU MDR 2017/745] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

Checklist – What is important before the EU MDR Date of Application?

1 Minute
It is Day -30 for the EU MDR date of application. So let's summarize what should be ready for you and also what is not mandatory.

The post Checklist – What is important before the EU MDR Date of Application? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

How to perform correctly a Merger & Acquisition during the MDR transition?

1 Minute
Merger and Acquisition is an important topic to understand as people think this is a fiance activity. But when you'll listen to this episode, you will not think that anymore.

The post How to perform correctly a Merger & Acquisition during the MDR transition? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Medical Device made Easy Podcast

Medical Device made Easy Podcast

Learn how to put a compliant Medical Device on the market