Learn more about the Plastics Industry Association’s Change and Certification of Materials in Medical Devices Resource Guide. Join the WEBINAR on September 24th from 11:00 a.m. EST to 12:00 p.m. EST.

When change does happen, it can take countless hours trying to understand the exact circumstances in which customers or members of the supply chain need to be notified of a change, what type of testing is needed, and what resource guidance is necessary to complete or provide. 

This guide assesses a comprehensive range of changes, including those to chemical components, production processes, product certifications, quality agreements, and product specifications. The guide uses an assessment methodology to identify the specific requirements that would apply to proposed changes, and identifies the appropriate actions that would be required or preferred.

The intention of this guide is to unite industry under commonalities and best practices for product and change certification, thereby reducing the time required for proposed material or process changes. The resource guide helps with making change management processes and decision making more efficient and, ultimately, it plays a role in making the medical supply chain an easier to navigate domain when it comes to changes.

Originally, this resource guide was written with the target audience being quality assurance and regulatory affairs representatives in each company.  It was designed as a resource tool to assist with understanding the requirements of the change and scope of the change management project.  Now, this resource guide can also be used far beyond its original intention.  For example, this resource guide can now be a resource for business and operations managers to fully evaluate the scope of a change management project.