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Medical Device made Easy Podcast Archiv

417 Episoden

Why would you need a Swiss Authorised Representative and Importer?

1 Minute
What is the role of a Swiss Authorized Representative and Swiss Importer? And most importantly why would you need one? I'll tell you everything on this podcast episode.

The post Why would you need a Swiss Authorised Representative and Importer? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

How to be great at Management Reviews? [ISO 13485]

1 Minute
Management Review is one of the most important activity to perform before to be ISO 13485 certified. So today I will explain to you how to be great at it.

The post How to be great at Management Reviews? [ISO 13485] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

Why Design History File (DHF) is so important? [Alexandros Savvidis]

1 Minute
DHF is an accronym that people don't really understand and in this episode Alexandros Savvidis he tries to help us have a view of his experience.

The post Why Design History File (DHF) is so important? [Alexandros Savvidis] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

Medical Device News: February 2022 Regulatory Update

1 Minute
All the February 2022 updates on MDR and IVDR, Clinical requirements and some news on the guidances and Notified Bodies.

The post Medical Device News: February 2022 Regulatory Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

MDCG 2021-27 Placing on the market & Re-labelling with Erik Vollebregt

1 Minute
The use of certain wording can be a big problem and this is what we will describe here with this MDCG guidance that is not really clarifying the situation but creating more problems. Let us tell you.

The post MDCG 2021-27 Placing on the market & Re-labelling with Erik Vollebregt appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

How to interview your QA RA Candidates? [Mitch Robbins]

1 Minute
What is your method to perform an interview? You are not trained as a recruiter so how should you do to interview a QA RA Candidate. This is what Mitch Robbins will explain to you on this episode. So no more misses.

The post How to interview your QA RA Candidates? [Mitch Robbins] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

How to accelerate your Laboratory Test Results? [Christoph Lindner]

1 Minute
Lab Tests can be really tricky for the success of your Medical Device Design. We will help you in this episode to understand with Christoph Lindner. Check show notes for more details.

The post How to accelerate your Laboratory Test Results? [Christoph Lindner] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

Medical Device News – January 2022 [Happy New Year]

1 Minute
HAPPY NEW YEAR 2022! Another year passed and this went really fast. But the Medical Device News is still here. So today we will talk of all the releases done in December 2021 and what is planned for the following months. Don't miss it. This will save you a lot of time.

The post Medical Device News – January 2022 [Happy New Year] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

What happened in 2021? Summary for the Medical Device Industry

1 Minute
I know, already the end of 2021. So many things happened that this may be difficult to summarize. So I've tried to put my TOP information on this episode. I also share with you the new projects for Easy Medical Device so don't hesitate to contact us if you need our support.

The post What happened in 2021? Summary for the Medical Device Industry appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

The Step-by-Step recipe to get MDR & IVDR Certified

1 Minute
For this christmas season, I wanted to summaries the situation on how to get MDR & IVDR certified. So i made this step-by-step recipe where you just need to follow. I hope you'll enjoy.

The post The Step-by-Step recipe to get MDR & IVDR Certified appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

Which devices cannot be Custom-made? [Erik Vollebregt]

1 Minute
If you are not aware, the EU MDR 2017/745 is completely changing the definition of Custom-made devices and this is mainly what we will try to explain to you on this episode. If you still have some question,s don't hesitate to contact me.

The post Which devices cannot be Custom-made? [Erik Vollebregt] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

Medical Device News: December 2021 Regulatory Update

1 Minute
Here is the last Medical Device News for this year, I will cover all the updates that happen in the EU, UK, Switzerland,, US and Saudi Arabia. We will also review the situation for Notified Bodies. I hope you'll enjoy.

The post Medical Device News: December 2021 Regulatory Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

Let’s unleash “MDR Classification surprises” [MDR 2017/745]

1 Minute
The MDR classification was hidding some surprises and I have asked Frank Matzek from Biotronik to tell us more about the products and rules we need to take care of. So Enjoy!

The post Let’s unleash “MDR Classification surprises” [MDR 2017/745] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

How to approach your Notified Bodies? [Dr. Royth von Hahn – TÜV SÜD]

1 Minute
Really great discussion with Dr Royth von Hahn from TÜV SÜD. He is providing some solutions on how to talk to your Notified Body. This would help Medical Device manufacturers.

The post How to approach your Notified Bodies? [Dr. Royth von Hahn – TÜV SÜD] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

Is it possible to Private Label a Medical Device under MDR & IVDR?

1 Minute
OEM OBL is really used a lot by Medical Device Manufacturers. But this is not possible anymore with EU MDR. So please listen to that as maybe you are doing it without knowing.

The post Is it possible to Private Label a Medical Device under MDR & IVDR? 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