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Compliance issues can impact organizations in many ways. For medical device companies, this can be in the form of the FDA’s unique device identification (UDI) requirements. These requirements, a result of the passage of The FDA Amendments Act of 2007, stipulate that most medical devices carry a unique device identifier.
A webinar addressing how enterprise data management enables UDI compliance was presented live on May 23, 2013 in a joint session with Kelle O’Neal of First San Francisco Partners and Ross Hart of Riversand Technologies.
During the presentation, the following areas were discussed:
- The FDA legislation and the impact it will have on your organization
- Current UDI data challenges and benefits
- How enterprise information management and PIM support UDI
- How to get a UDI program started
- How to ensure a successful UDI program
These are the slides used in Kelle's portion of the presentation.