Medical devices and their development is a world on its own. You understand that there is a CE Mark in Europe and a 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 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 one 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.
Course time09h00 - 17h00
Who should attend
Clinical Operations and regulatory staff from medical device companies or investigators and study co-ordinators involved in running clinical trials with medical devices.
- Regulatory medical device environment in Europe and US
- CE Mark and how to obtain it
- The future of medical device regulations in Europe
- To understand the regulatory environment for the development of a medical device
- To fully understand the legislation around medical devices in Europe
- To understand the basics of the US regulations for medical devices
- To understand the different routes for obtaining CE marking in Europe
- To get an insight on the future development of the medical device regulations in Europe
This course covers competencies that are part of the ECCRT Competency Framework:
- Ethical & Participants Safety Considerations (2)
- Investigational Product Development and Regulation (6)
- Clinical Studies Operations (GCPs or ISO 14155) (3)
- Study and Site Management (1)