Medical device OEMs have launched a new MedAccred critical process focus area for labelling, printing, and unique device identifier (UDI).
This will ensure that medical device information provided to medical staff and patients is reliable, accurate, complies with regulatory requirements and, most importantly, improves patient safety. The new assessment will help the medical device industry avoid costly warning letters and recalls by driving the adoption of stringent manufacturing process controls. It comes in response to changing and increasingly complex global requirements which place extra burdens on content management, product labelling, promotional material and UDI.
Paweena Limjaroen, PhD, senior director, Global Labelling and Packaging, Edwards Lifesciences, is chairing the new MedAccred Labelling, Printing and UDI Task Group to develop the industry MedAccred audit criteria, select subject matter expert auditors, and determine which companies meet the rigorous industry requirements to provide oversight for this critical process area. Limjaroen commented:
“In today’s ever-changing medical device-labelling landscape, it is more important now than ever to ensure labelling documentation is regulatory compliant. The MedAccred Labelling, Printing and UDI Task Group’s role is to provide medical device companies with structure and requirements to assist in identifying and implementing industry best practices for global market compliance.”