New Regulatory Framework for Medical Devices and In Vitro Diagnosis
This webinar is now finished. You can review the entire event via the above link and on our project youtube page.
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.