Running Medical Device Studies

Reasons to attend

You have clinical research experience in general, but somehow running clinical studies 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 studies. This course is also the core of our Medical Device STAR Programme.

What's included?

• Documents and materials related to this course are included
• Globally recognised certificates awarded after test completion

Course schedule

We provide this course in two distinct formats: Classroom OR Online

Classroom: 2-Day face-to-face: 09:00 - 17:00

Online: 3 webinar sessions of 4 hours

Course Description

This course focuses on the different phases of Medical Device Clinical Research, the different types of Medical Device studies, the regulatory framework and submission and approval pathways, a general overview of and the role of each team member (Sponsor, CRO (CRA, PM) and Site (Investigator, Study Coordinator) and other parties involved, as well as essential documents and data collection requirements. 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.