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Difference between MIR and FSCA report
What is the difference in MIR (Manufacturer incident report) and Report Form for FSCA?
Is 7th revision of MEDDEV is actual today?
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ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more 
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
Expert
Kristina Zvonar Brkić
Dec 19, 2022
Valid version of the MEDDEV 2.12 is Rev 8, published in January 2013.
These two documents are not for the same purpose. So, you need both of them. First, you need to make a report regarding some incident, and then, after you report it, you need to prepare the field safety corrective action. So you need both of them.
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Dec 19, 2022
Dec 19, 2022
Dec 19, 2022