First Audit Scheduled Under The Harmonizing Single-Audit Program
This article was originally published in The Gray Sheet
Executive Summary
The first audit under the Medical Device Single Audit Program of a globally marketed device was scheduled to occur this past week, according to CDRH Associate Director for International Affairs Kimberly Trautman. Initial inspections conducted by third-party auditors under the program will be witnessed by regulatory authorities as part of a recognition process.