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Will ‘Maturity Model’ Pilot Mean Fewer US FDA Inspections for Medtech?

This article was originally published in Clinica

Executive Summary

So-called 'mature' medical device companies could put off an inspection by the US FDA 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.

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