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Podcast: ISO 13485 Redo Takes Front Seat In Exclusive Interview With Ex-FDA International Quality Systems Expert Kim Trautman

This article was originally published in The Gray Sheet

Executive Summary

In her first interview since leaving the agency in January, FDA’s former international quality systems expert Kim Trautman – author of FDA’s Quality System Regulation and one of the chief architects of the global Medical Device Single Audit Program – talks to The Gray Sheet about what manufacturers should keep an eye on when it comes to quality systems standard ISO 13485, and also discusses her new role in the private sector.