BIORIUS can help you at different times, for example to:
- Define your MD indications
- Determine the MD classification
- Determine the appropriate procedure to obtain your CE marking
- Choose your Notified Body
The new regulations cause an increase in the number of MDs requiring the intervention of a Notified Body.
If you have never been through this type of assessment and if you don’t know the rules, you may fail or need much more time and money before you are allowed to put your device on market.