ISO 13485 & EU MDR / 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.
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We are currently making update dof our toolkit and some more information will be covered until June 2021.
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