Recent Posts
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How to perform correctly a Merger & Acquisition during the MDR transition?
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.
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How to write your Performance Evaluation? [IVDR 2017/746]
In this episode Hakan Inan will help us to write our Performance Evaluation specifically for IVD products.
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Medical Device News – April 2021 Update [EU MDR & IVDR]
In this episode, we will summaries what happened for the Medical Device Community. We will explain to you the last MDCG Guidances that were issued and the Notified Bodiy Situation.
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Will it be really difficult for IVD manufacturers? [IVDR 2017/746]
IVDR is planned for May 26th, 2022 but why it will be more difficult for IVD manufacturers than for MDR manufacturers? Listen to this episode to have a better understanding
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How to create a Label under MDR? (Questions & Answers)
During the Greenlight Guru summit on EU MDR & IVDR I have presented the way to create a label. And following the session there was so many questions that I decided to answer to some of them within the Podcast so everyone can benefit from it. So I hope this will help.
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How System and Procedure Pack are regulated under EU MDR?
The system and procedure pack within EU MDR is still a mystery for a lot of people and Erik Vollebregt accepted to help us have a better understanding of this specific cases. We will explain to you what it is and who can use it.
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How to import your Medical Devices with an Independent Importer?
In this episode, Edgar Kasteel will help us understand the role of an importer and will also tell us more about the model of independent importers.
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What is the Medical Device News? [March 2021 update]
In this monthly episode we will review what happened within the Medical Device industry. EUDAMED, Covid19, Notified Bodies...
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The best design methods for successful development? [Jon Speer]
Waterfall or Agile? Jon Speer from Greenlight Guru will help to understand what is the best methodology that can be used to develop your medicaldevices.
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How to find a QA RA job for Medical Devices? [Karandeep Badwal]
How to find a job in the QA RA world for Medical Devices? This is what we will discuss with Karandeep Badwal. We will provide our tips and also the platforms to visit.












