In this episode, Stefan Bolleininger will explain you can save money on your MDR or IVDR submission just by choosing the right MDR or IVDR code and by following some of his advice.  Who is Stefan Bolleininger?   Stefan Bolleininger is a key opinion lea

Medboardhttps://www.medboard.com/EUUrgent update needed - EU MDR and IVDR: https://www.europarl.europa.eu/doceo/document/TA-10-2024-0028_EN.pdfHMA communication: https://www.hma.eu/fileadmin/dateien/Medical_Devices/CGMD/241018_Letter.pdfEU Commis

In this episode, Adam Isaacs Rae will help us shape your Regulatory Compliance Strategy. This is a requirement of the EU MDR and IVDR but it doesnt provide much information. So, lets review that together.Who is Adam Isaacs Rar?Chartered quality profes

in this episode, Georg Digel will help use solve 3 major problems with our CAPAs. He will tell you what these problems within your Quality Management System are and propose some solution. We will also talk about the education of the team.Who is Georg

Medboard: https://www.medboard.com/EUROPETEAM NB - Code of Conduct for NB - Version 5: https://www.team-nb.org/wp-content/uploads/2024/09/PressRelease-CoC-20240916.pdfTEAM NB - IVDR Transition - Transition to the implementation of Class D oversigh

In this episode, Lucas Pianegonda will help us to select the right material for your medical device and also answer questions that you maybe would love to hear his answer. We will also talk about sustainability for plastics. So check this. Who is Lucas Pi

In this episode, Claire Dyson will give us the recipe to launch correctly your Medical Device when you go abroad and for that we will take the example of EU and US.Who is Claire Dyson?Claire Dyson is a seasoned professional in the Med Tech space havin

In this episode, Cesare Magri will try to improve our skills on PMCF literature search. We will investigate on the misconceptions and what people should make to do it right.Who is Cesare Magri?Cesare Magri is the founder and CEO of 4BetterDevices Gmb

EUe-IFU for medical devices - Consultation ongoing: https://ec.europa.eu/eusurvey/runner/Survey_eIFUs_medicaldevices_2024?surveylanguage=ENMDR Transition period - Visual timeline: https://health.ec.europa.eu/document/download/06bb3982-dc01-46aa-95af-

In this episode, Martin King will share with us his practice of AI in the context of Quality and Regulatory affairs for medical devices. This will explain to you some best practices to maintain to avoid some pitfalls.  Who is Martin King?  Martin Cranston