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.


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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

Join us for ‘How the GUIDID was it?’ on 27th January 2016 at 3PM GMT / 10AM New York to discover how UDI has changed the medical device labeling landscape and how we can all learn from it to reduce risk, increase efficiency and meet regulatory requirements in the future.

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