How The GUDID Was it?
Implementing and achieving UDI compliance – have the benefits of UDI outweighed the pain?
For the sake of patient safety, the ability to track and trace medical devices at a global level is paramount. In the last couple of years the fruition of the FDA’s UDI (Unique Device Identification) requirements - a single global regulation for uniquely pinpointing medical devices in the supply chain - has meant that all medical device companies trading in and to the USA must comply.
As part of the directive, organizations must submit product information in a computer-readable structured labeling format to the GUDID (Global Unique Device Identification Database) - a publicly searchable database. For many, the journey has not been a simple path and many organizations have had to make huge changes to their internal and labeling processes to stay compliant.
In a 2015 survey, 74% of manufacturers stated that the key driver to make changes to their labeling process was ensuring regulatory compliance, yet 62% would find it difficult to assess the impact of making changes to their system. Time-lining when and how to make essential changes to stay compliant with regulations while keeping the production line rolling is a tough balancing act, and this webinar looks at how well companies have managed the change.
Presented by Speakers:
- Kevin Grygiel - VP of US Sales, PRISYM ID
- Gary Saner - Snr Manager, Information Solutions - Life Sciences, REED TECH
- Neil Piper - Consultant, GS1
Key Learning Objectives:
- Learn how the UDI requirements have affected labeling and labeling processes
- Discover what the main challenges were, and how manufacturers are continuously working to meet them
- Ascertain if you’re ready for an FDA inspection which includes UDI activities
- Gain a greater understanding of making your labelling processes more efficient, compliant and risk free