Reasons to attend
You have clinical research experience in general, but somehow running clinical trials with medical devices still has some secrets for you?
This course will provide you with a very practical set of information, tools, and knowledge that will ultimately increase your competency level for running medical device trials. This course is also the core of our Medical Device STAR Programme
- Documents and materials related to this course are included
- Globally recognised certificates awarded after test completion
- This course has been granted PharmaTrain Recognition
Two Day face-to-face training: 09h00-17h00
Webinars: 5 sessions of 2 hours
This course focuses on the different phases of Medical Device Clinical Research, the life cycle of device development, ISO14155 and the role of each team member (Sponsor (CRA, PM) and Site (Investigator, Study Coordinator). This course is specifically designed for people with a strong interest in Medical Devices, with or without a long track record.
In addition to theory, interactive workshops will introduce the participants to the operations of Medical Device Clinical Research from each of their positions and roles. It will highlight how things are different compared to trials with medicinal products. The workshops will be organised as breakout groups to allow approaching the various topics from the different positions involved.