Lori A. Carr and Timothy Schmutzler

Regulatory consultant Lori Carr can be reached at loriacarrinc@comcast.net. Timothy Schmutzler, regional VP of GRC Solutions, MetricStream, can be reached at tschmutzler@metricstream.com.

Avoiding FDA warning letters

By establishing robust quality & compliance management programs, medical device manufacturers can ensure process quality and product safety in compliance with FDA mandates.