General
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We’ve reached episode 100 – What happened for the last 2 years?
We have reached 100 episodes on the podcast and today we will celebrate that. Here is an episode with some of the great influencers in the Medical Device field which are sharing with us their journey. What happened to you since the last years.
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The latest news on Brexit, Swixit and EU MDR [Medical Device News]
This month a lot of exists on the Medical Device news. We are still under a pandemic so conferences are going virtual and Easy Medical Devices has the best training for EU MDR.
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How to register ATMP-Device combination products?
ATMP is a category of product not so well known by the regulatory affairs professionals. I wanted to help you understand how they are working with Margareth Jorvid. She will provide us with a specific overview for ATMP-Device combination products.
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Medical Device News – August 2020 Review (Monir El Azzouzi)
In this episode we will talk about the UDI FAQ, the new regulation for reprocessing of single use devices, the EUDAMED actor module, the new Guidances released... A lot to discuss today.
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Best practice for Device Testing with Michael Wetherington
Medical Device Testing is something all medical device manufacturers should perform. How can you prove that your device is safe and performing without that. So now how to do it? Michael Wetherington from Medical Regs will be my guest on this episode of the podcast. He will share with us all best practices.
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Best overview of IEC 60601 for Medical Device electrical equipment
IEC 60601 is one of the most important standard to look at if you have an electrical medical devices. In this episode Leonard Eisner also called the IEC 60601 guy will help us understand the full situation. So be ready to learn a lot today.
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Medical Device News – July 2020 Update on Quality and Regulatory for Medical Devices
In this monthly update we will review some hot topics that happened within the last weeks., the Notified Body Situation, the Guidance and standards update and finally what happened at Easy Medical Device.
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Medical Device News – June 2020 Update
During this update, we will talk about the Coronavirus situation, the Notified Body accredited, the CEN CENELEC mandate for Harmonized Standards, the Green Belt Certification Program. A lot to say and also a Trailer for the EU Commission Telenovela.
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Medical Device News – April 2020 Regulatory Update
Medical Device News April 2020- We will talk about how Coronavirus is shaking the Medical Device World, the Notified Body Situation, the MDCG guidances and the Easy Medical Device events. Enjoy!
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Medical Device School – Why are Staff hiding problems to QA & RA?
If you are not working in QA RA you maybe don't understand this. But sometime people don't want to follow the process not because they want to annoy you but because they are afraid of some consequences. And they try then to find other ways. Let's explore them with Karandeep Badwal
