You have clinical research experience but the field of medical devices is new to you? Then this one day introductory course is something for you. It will give you the overview, allowing you to understand the fundamental concepts of clinical trials with medical devices and the differences with the pharma R&D.
We will work through definitions and classification of different types of medical devices and touch on the main differences with pharmaceutical products. You will get familiar with terms typically used in this industry. and learn about the high level medical device regulatory context in both EU and US.
It also serves as a wonderful opening of our Medical Device STAR Programme.
Course time09h00 - 17h00
Who should attend
Everyone involved in clinical research who recently entered or will enter to the medical device field.
- Definitions and classification of medical devices
- Overview of European and US medical device regulatory requirements
- Differences between drug and device clinical trials
- To differentiate between various types of medical devices
- To understand the basics of European and US medical device legislation
- To identify documentation requirements specific to medical devices
- To recognize differences between drug and device development