'Maturity Model' Pilot Might Mean Fewer US FDA Inspections For Medtech
This article was originally published in SRA
Executive Summary
So-called 'mature' medical device companies could put off an inspection by the US Food and Drug Administration for a few years if they independently verify that they have robust metrics in place to gauge manufacturing and product quality, according to a pilot program that the agency hopes to set up by the end of 2017.