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I'm trying to get an idea of time and cost for a Notified Body to review a Design Dossier for a Class III implantable device. (not active, no medicinals or biologics) The device has completed clinical trial in the U.S. and received Premarket Approval (PMA) from the FDA.
I'd appreciate hearing what your experience has been with time and cost for the Design Dossier review.
Thank you.
I'd appreciate hearing what your experience has been with time and cost for the Design Dossier review.
Thank you.