Speaker: Dr Cornelia List
The goal of this training is to provide participants with an introduction of substance-based devices and its associated challenges under the EU Medical Devices Regulation (Regulation (EU) 2017/745). The training is aimed at anyone who seek to enhance their knowledge and competences within this field.
By attending this training, you will receive an introduction on what is a substance-based product and how it qualified as such. After a general introduction of substance-based devices and its requirements to be considered for a regulatory pathway the focus will lie on substance-based medical devices falling under rule 21.
- Regular regulatory pathway of substance-based products
- Qualification of a substance-based product
- Risk classification (in case of a substance-based medical device)
- Additional requirements
- Presentations with interactive discussions
- End of training assessment
EUR 415 incl. course material and certificate