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FDA's Single-Audit Point Person Sees Device-Maker Benefits In MDSAP Initiative

This article was originally published in The Gray Sheet

Executive Summary

Kim Trautman, the FDA official working closely with the International Medical Device Regulators Forum on its Medical Device Single Audit Program pilot, envisions many benefits to industry participation, including easier compliance with international quality systems standard ISO 13485 as well as input on the MDSAP program as a whole, she said in an interview.

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