The new regulations of medical devices will strongly impact the companies. BIORIUS helps you to overcome this challenge.
The European regulation of Medical Devices is demanding, a lack of experience and resources can lead to mistakes and costs. Consult your regulatory expert!
As requested, Technical Documentation must be available and kept up to date for all Medical Devices placed on the market in the EU. Biorius can help you in this task!
Choice of your Notified Body
Thanks to its expertise, BIORIUS guides you in the choice of a Notified Body and much more.
Thanks to its expertise, BIORIUS helps you to manage the planning and evaluation of the biological safety of your MDs