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MDD position on Final Inspection/Release Employee Experience/Training

P

pandora412

#1
Is there a reference in the MDD regarding the experience/training required for the person performing final inspection/release of product? I can only find specifics regarding 3rd part inspection.
 
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S

SteveK

#2
There isn't a direct indication. Annex II indicates:

The manufacturer must ensure application of the quality system approved
for the design, manufacture and final inspection of the products concerned


So it is indirectly covered by the requirement of the QMS i.e. the competence (HR) section of ISO 13485 - 6.2.:2cents:

Steve
 
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