D
DrG
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Thanks Tim for the clarification.
So If I understand correctly:
a)-If I have an FDA validated workflow such as Straumann CARES, I am covered because the whole workflow has been 510k cleared
b)-If I have a mix of CADCAM equipment with a non 510k cleared workflow, I need to implement the Quality System and document the procedures.
Now there is a cost and precious time associated with b): how much ?
So If I understand correctly:
a)-If I have an FDA validated workflow such as Straumann CARES, I am covered because the whole workflow has been 510k cleared
b)-If I have a mix of CADCAM equipment with a non 510k cleared workflow, I need to implement the Quality System and document the procedures.
Now there is a cost and precious time associated with b): how much ?