Worldwide
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Why Risk Management is important to Medical Device development?
Why is Risk Management so important? This is maybe something that a lot of regulators are asking you. "Do you have your Risk Management?" In this episode, we will explain to you why this is most critical information to get.
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Medical Device News – November 2022 Regulatory Update
What happened to the Medical Device industry? Let's learn in this episode with Monir El Azzouzi
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How to be MDSAP certified for your Medical Devices?
MDSAP is now in place since few years. For those that still have no understanding of it, I will tell you all on it from who needs it to how to be prepared for it. Enjoy!
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Why do you need an Initial Importer for the US Market?
This is not anymore a question, you need an Importer for the US market. But what are the rules and who can do this. Stéphen Toupin from Dawa Medical will help us understand why your products are blocked at the US Customs.
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Medical Device News – July 2022 Regulatory Update
This podcast episode is the monthly review of the regulatory situation. Don't forget to download the document with all the links.
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Attention! 1 year before UKCA is the law for Medical Devices in the UK
This is your last year to be compliant to UKCA otherwise Bye Bye the UK market. We tell you everything with Adam Rae on this episode. So listen carefuly and don't forget to download the cheat sheet.
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Medical Device News: December 2021 Regulatory Update
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.
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Medical Device News – November 2021 latest update
Latest update will focus on IVDR proposal, Artificial intelligence, Notified Bodies situation and MDCG guidances. Other elements will also be discussed. I hope you'll enjoy!
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Medical Device News – October 2021 Regulatory Update
Here is the Regulatory update for October 2021. We will talk of the Implementation of MDR and IVDR, MHRA, Swissmedic, FDA, AEMPS.. A new session of the Green Belt opens this month.
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Medical Device News – September 2021 Latest Updates
On this September 2021 update we will talk about FDA, MHRA, Swissmedic, ANSM, Fimea, MDCG guidances, New Notified Bodies... A lot to talk about so don't miss this update. If you are not willing to read the guidances, let me summarize it for you.
