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QUOTED. 4 February 2020. Kim Trautman.

Executive Summary

The new US-Mexico-Canada (USMCA) free-trade agreement aims to make it easier for the three countries to align on inspecting medical device manufacturing facilities by using the Medical Device Single Audit Program (MDSAP). Former US FDA official Kim Trautman explains how Mexico – which currently doesn’t accept the results of MDSAP audits – can come up-to-speed with the program.

“There are different ways that [Mexico] has available to become familiar with the MDSAP audits and program requirements for them to gain the assurances they need to understand how best they might use MDSAP in their regulatory framework.” – Kim Trautman, executive VP of health sciences, NSF International

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