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.
Join us for ‘How the GUIDID was it?’ on 27th January 2016 at 3PM London/ 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.
Presented by
Kevin Grygiel,
VP of US Sales, PRISYM ID
Kevin Grygiel, Vice President of US Sales at PRISYM ID, has over 15 years' experience in software development and implementation helping to deliver complex and personalized business solutions to Life Sciences customers.
Kevin has a proven ability to focus, align and build effective teams with an uncompromising regard for customer impact. He also has the ability to conceptualize, develop and deliver innovative solutions and services that address and resolving enterprise-wide business needs resulting in a high degree of customer loyalty and retention.
Gary Saner,
Sr. Manager, Information Solutions – Life Sciences REED TECH
Gary Saner, Sr. Manager of Information Solutions in the Reed Tech Life Sciences group is a subject matter expert on UDI and other structured content submissions to regulatory agencies. He has over a decade of experience in the Life Sciences industry and has worked for over 30 years in the areas of software development, process management and data conversion.
Gary is an active member of the HL7 SPL Working Groups and co-chairs the HL7 Technical Team. He is a frequent presenter at industry conferences for regulatory and other Life Sciences professionals. He holds a bachelor's degree in Mechanical Engineering from LeTourneau University with graduate studies in Computer Science and Statistics at Villanova University.
Neil Piper,
Consultant, GS1
Neil is an expert in his field and he has been working for GS1 for seven years.
GS1 UK is a community of over 29,000 members working in retail, foodservice, healthcare and more.
They are one of 112 independent, not-for-profit GS1 organisations operating across 150 countries worldwide.
