New Regulatory Framework for Medical Devices and In Vitro Diagnosis
On Thursday July 16th AT 10am BST/ 11am CEST, Atlantic KET Med presents the third in its Webinar Series for Med Tech SMEs. This time we will be exploring:
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 Medical Device Regulation (MDR) or In-Vitro Diagnostics Regulation (IVDR)
CE mark: Importance of the Technical documents
General safety and performance requirements (GSPR)
Technical standards and guidelines
Performance evaluation under MDR / IVDR
Asphalion, a globally renowned scientific and regulatory affairs consultancy will provide the training.
To attend the Webinar, please pre-Register here
Once registered you will receive a personal link by email that you will use to access the live Webinar.