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Vigilance

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Guest user Created:   May 10, 2021 Last commented:   May 13, 2021

Vigilance

Vigilance is one requirement for MDR but cannot be found in the template. Is Vigilance included in 18_Post_Market_Surveillance?

 

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ISO 13485 & EU MDR INTEGRATED DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 & EU MDR INTEGRATED DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Tiffanie May 11, 2021

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!

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Kristina Zvonar Brkić May 13, 2021

We are currently making update dof our toolkit and some more information will be covered until June 2021. 

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May 10, 2021

May 13, 2021