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Difference between MIR and FSCA report

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Guest user Created:   Dec 19, 2022 Last commented:   Dec 19, 2022

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.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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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

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