Production line for medical devices

andrei iuganu

Involved In Discussions
#1
Hello all,
what standards must an automatic production line meet for medical devices? - the field of activity is plastic injection - pipette head, rack, box, lid, etc.
the automatic line will take over the products from the mold through various devices, will place / assemble them, then will pack them.
 
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yodon

Staff member
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#2
I don't think there are any particular standards that must be met (ignoring things like OSHA). As with any process whose output is not 100% verified, the process will require validation (and the equipment qualified). It's probably a good idea to do a process FMEAto and mitigate any risks along the line.
 
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