IVDR 2017/746
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MDCG, Team-NB, BVMed & Team-PRRC tell you all about PRRC
If you have a question about the role of a PRRC then most likely this will be answered by one of those expert. This podcast will display the Team-PRRC event where EU commission, Team-NB and BVMed answered the questions of Bassil Akra Board member of Team-PRRC
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Your Software/IVD clinical report is completely WRONG!
If you are in the Software and IVD industry we would bet that you are making your clinical data gathering wrong. Cesare Magri will explain to you why and how to correct that. So listen carefully to his advise.
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Can you go to Jail as a PRRC? [Elem Ayne]
You are maybe asked to become a PRRC and you start to have a lot of questions. I am sure these are the questions that you ask yourself as this is also what other people are willing to know. They contacted Elem Ayne at Team PRRC and the association is trying to help them understand the situation.
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Medical Device News: September 2022 Regulatory Update
Medical Device News is your summary of what happened in the Medical Device Field. I am providing you with the September 2022 Regulatory Update. Enjoy!
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New Blue Guide – What is the impact on Medical Devices?
The New Blue Guide is a guidance document that is really important to CE marking. And this has also some impact on the interpretation of the Medical Device legislation like EU MDR and IVDR. So don't miss this episode where we interpret what are the major changes.
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How to create your Technical Documentation? [EU MDR and IVDR]
I get a lot of messages about the creation of Technical Documentation and I want to share with you how I am doing it. Don't hesitate to check the link in the show notes for more details.
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Medical Device News: June 2022 Regulatory Update
Medical device news June 2022 is focusing on IVDR 2017/746 date of applciation and consequences. Don't miss all the additional information on guidances, Training,,,
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What happens after the IVDR Date of Application with Colm O’Rourke
The IVDR 2017/746 will go live and this may be a big problem for a lot of companies. We will talk about that with Colm O'Rourke from Trinzo. The IVDR is changing the game so learn about it.
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What are the surprises during MDR & IVDR transition? [Erik Vollebregt]
We update you on the situation regarding the MDR and IVDR transition period. Erik Vollebregt will try to provide an explanation why the EMA will now take the control of the Expert Panel for Medical Devices and also why the proposal for a 2 years or more additional transition will be needed.
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How to sell Medical Devices online in the EU and US?
If you are selling medical devices online or if you plan to sell some, then this episode is for you. This will help you to understand the struggle that you may have or will encounter. Michael Wetherington and I will provide you the keys to be successful in that field.
