IVDR 2017/746
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Responsibility of a Distributor in MDR & IVDR with Nicolaj Nitzsch
What is the role of a Distributor within the new MDR 2017/745 and IVDR 2017/746. This is the question that I asked my guest who is working as distributor of Medical Devices in Norway.
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EUDAMED is delayed, so What? with Richard Houlihan
EUDAMED is delayed but what should do Medical Device manufacturers to continue be compliant. Richard Houlihan is a EUDAMED expert and will help us understand.
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Medical Device Disruptions at Hospitals with Stefan Krojer
Some signs are raising from Hospitals regarding disruptions on Medical Devices. What is exactly the reason. Stefan Krojer will share with us his experience and a solution he is developing.
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New rules for the In-Vitro Diagnostic Industry with Maurizio Suppo
In-Vitro Diagnostic Regulation will come later and we have time. Maurizio Suppo do have another opinion and as he is really passionate about this topic he will be providing some golden advice that you should not miss. Even for non-IVD manufacturers as we will talk about a proposal if manufacturers cannot meet the deadline.
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Episode 33 – Notified Bodies Lay Down Service with Erik Vollebregt
One important piece of the puzzle for the new Medical Device Regulation is about Notified Bodies. More and more we receive the information that some of them decide to Lay Down Service. What are the consequences for manufacturers? What is a solution for them? Erik Vollebregt will be my guest on this episode.
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Episode 29 – 5 Steps to create a QMS with Jason Lim
Jason Lim will reveal to us what are the 5 steps to create a good Quality Management System or QMS.
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Episode 28 – OBL & OEM with Stefan Bolleininger – Part 2
How an OEM or Original Equipment Manufacturer can help the OBL (Own Brand Labeller) to continue business? Stefan Bolleininger from Be-On-Quality will help us on this second part of the Podcast.
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Episode 27 – OEM & OBL Model with Stefan Bolleininger [Part 1]
The OEM and OBL model is under question with the new EU MDR and IVDR regulations. Stefan Bolleininger will help us understand how to continue to be compliant and continue business.
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Episode 26 – IVDR preparation with Andreas Stange
Andreas Stange from TÜV SÜD will help us be prepared for the new IVDR or In-Vitro Diagnostic Regulation. This is a game changer for the manufacturers as more products are on the scope of a notified Body certification.
