The ATLANTIC KET MED project continues to carry out training activities in webinar format.

The main theme of the next webinar will be the New Regulatory Framework for Medical Devices and In Vitro Diagnostics.

July 16th. 11:00h CEST (Madrid hour). 10:00h (UK hour)

New Regulatory Framework for Medical Devices and In-Vitro Diagnostic

  • What does CE mark mean?
  • What is a Medical Device and In-Vitro diagnostic?
  • Classification system: concepts and rules
  • Milestones to CE Mark

Regulatory Concepts to CE Mark under MDR or IVDR

  • CE mark: Importance of the Technical documents.
  • General safety and performance requirements (GSPR).
  • Technical standards and guidelines.
  • Product risks analysis
  • Performance evaluation under MDR / IVDR​

Asphalion, an international scientific and regulatory affairs​ consultancy  will provide the training.

Once registered you will receive a personal link by email that you will use to access the live Webinar.