Medical devices and their development is a world on its own. You understand that there is a CE Mark in Europe and an FDA approval process in the US, but how do you get this? You hear a lot about medical device development on how this is regulated, but you do not have the full insight on how these regulations now actually are? You want to understand how those regulations have an impact on the clinical research and the development in general of new medical devices?
This course will provide you with all the answers you need about current medical device directives as well as upcoming regulations in both EU and US. This course is also the cherry on the cake for our Medical Device STAR Programme.
In this 1-day training, we will dive in the detailed regulatory environment of Medical Devices. Focus is on Europe but US regulatory environment will be touched as well. We will learn about standards, directives and regulations and will talk extensively about CE marking routes.
We will conclude with a forward-looking section on the ongoing changes and the future in Medical Device regulations in Europe. We will also look at regulations of the growing area of device-drug combination products.