Dramatically Reduce the Complexity and Cost of Compliance of UDI
In order to improve patient safety, the FDA created a new regulation requiring the standard identification of every medical device throughout its supply chain journey. To meet this newly proposed regulation for UDI (Unique Device Identification), medical device manufactures and their suppliers must label every product, product version, and product configuration with a unique, 14-digit identifier. What's more, a wide range of critical device information is required to be submitted to the FDA's new GUDID (Global Unique Device Identifier Database) to more effectively track adverse events and safety issues to specific products. Not complying with this regulation would bar device sales across state lines, which means that noncompliance is not an option for medical device manufacturers in the US.
Working with the FDA and major medical device manufacturers, PTC has developed an efficient, cost-effective solution to help companies manage UDI submissions and gain compliance, while ensuring scalability to meet future FDA or worldwide requirements for UDI.
The PTC UDI Solution:
- Communicates and Tracks UDI requirements, providing automatic data formatting and submission, FDA response monitoring for quick correction, and enterprise-wide compliance reporting
- Governs the UDI submission process by supporting 21 CFR Parts 11 and 820 with secure electronic records, technology validation, and fully documented training, all within a scalable software architecture to meet emerging global UDI requirements
- Manage and Synchronize changes to keep UDI submissions current with product updates, offering capabilities to collect and control UDI data from across the organization with OOTB templates, preconfigured workflows, and change/configuration management
The PTC UDI solution combines OOTB technology, services, and training to offer an end-to-end solution for managing UDI submissions.