Medical Device Regulations

Reasons to attend

Medical devices and their development is a world on their 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 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 the US. This course is also the cherry on the cake for our Medical Device STAR Programme.

What's included?

• Documents and materials related to this course are included
• Globally recognised certificates awarded after test completion
• This course has been granted PharmaTrain Recognition

Course schedule

Classroom: 1-Day face-to-face: 09:00 - 17:00

Online: 2 webinar sessions of 3 hours

Course Description

In this 1-day training, we will dive into the detailed regulatory environment of Medical Devices.

The focus is on Europe but the 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.