Navigating through the MDR & FDA universe

As a medical device manufacturer, you are key to improving healthcare quality and affordability. But during your innovative journey, a crucial crossroads awaits you - choosing the regulatory route that will make your device a global success. Using a real-life case study from Medical Precision, Unitron will take you by the hand to unravel the complexities of two regulatory frameworks: the US FDA (Food and Drug Administration) and the EU MDR (Medical Device Regulation). How to tackle the problem of the shortage of notified bodies?

Our experts Nico Zeeders (Manager Regulatory Affairs at @Unitron) and Blerta Kukaj (QA Manager and Operational coordination at @Medical Precision) will guide you through the essential classification and clinical evaluation differences that can significantly affect your device's market access and growth potential. And what is the role of the distributor regarding this topic?

02-11-2023 15:15 - 16:15