Session 1: Implementation Strategies for IVDR – Timelines and Priorities – Work Packages

Don’t miss our e-Learning on IVDR implementation strategies.

In a series of 9 sessions we will help you to understand how the new IVDR will affect your product.

This first IVDR e-Learning session is focussed on how to kick-off the implementation planning for the IVDR transition. Based on an exemplary transition plan, priorites as well as work packages to be assigned will be discussed.

 

More topics to be covered in the upcoming sessions

  • How REACH affects Medical Devices and IVDs
  • Classification under IVDR
  • Economic operators and regulatory functions under IVDR
  • Performance evaluation and clinical evidence under the IVDR
  • Update of the technical documentation meeting IVDR requirements
  • Post market surveillance and vigilance under the IVDR
  • EUDAMED and UDI under IVDR

After confirmation of your registration by knoell Germany GmbH, you will receive a link and an access code. From the time you receive the access code, the link to the e-Learning video is valid for 56 days. The video can only be accessed five times during this period.

Details
Target audience: 
Regulatory Affairs Manager, Quality Management, Transition Manager
Language: 
English