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 which will ultimately increase your competency level for running medical device trials. This 2-day course is also the core of our Medical Device STAR Programme.
This 2-day course is focussing 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). These 2 days are 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.