Manufacturers Struggle To Determine Unique Device Identification’s Impact
This article was originally published in The Silver Sheet
Executive Summary
Unique Device Identification (UDI) will touch many parts of a manufacturer’s quality system, including CAPA, complaint handling, design control, design history files and management control, among several other areas. “Your quality system is going to be affected in any area where you deal with a product identifier,” Philips Medical Systems’ Michael Hudon points out. Many firms have already formed UDI implementation teams as they await FDA’s final regulation on the topic.