Vigilance is one requirement for MDR but cannot be found in the template. Is Vigilance included in 18_Post_Market_Surveillance?
ISO 13485 & EU MDR INTEGRATED DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more 
ISO 13485 & EU MDR INTEGRATED DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 13485 & EU MDR INTEGRATED DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
I agree - I've been reviewing the Adverse Event Investigation and Reporting procedure but I don't think it covers all the mandatory requirements under the MDR. Do you have any materials or other templates or SOPs that can help us with preparing a compliant vigilance SOP? Thanks!
We are currently making update dof our toolkit and some more information will be covered until June 2021.
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May 13, 2021