What do we know currently about the UDI initiative for medical devices?
This webinar focuses on the current global unique device identification (UDI) activities, the trends and timelines, and the past and expected future challenges in implementing unique device identification.
Medical device UDI and in vitro diagnostic medical devices is now an international hot topic. How you, as a manufacturer, respond will affect your bottom line in the coming years. Regulatory unique device identification requirements started with the US, spread to the European Union, and are now emerging in South Korea, Saudi Arabia, China, and elsewhere. In parallel, your commercial business partners are starting to revise their contracts to specify unique device identification be placed on products and be included in electronically published product catalogs.
With regulatory and business changes already in process, it is necessary for medical device manufacturers to evaluate the UDI impact to their global markets, define a strategy, and start preparing their solution.
Gary Saner, Sr. Information Solutions Manager, reviews the advantages of a central product information management solution that will better prepare you to make an informed decision in defining your unique device identification roadmap.
What You Will Learn
- The known requirements of leading regulatory and commercial unique device identification adopters
- The differences and similarities of FDA unique device identification and EU unique device identification
- The growing difficulties in managing and reporting medical device information
- The advantages of a comprehensive, global strategy for unique device identification compliance
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