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Now that the UDI label and GUDID (Global UDI Database) requirement deadlines for class II devices have passed, many manufactures must implement solutions to meet the Direct Mark (DM) requirements for class II devices in 2018. And unlike the label requirements, which “simply” updated the current label with a UDI, the DM requirement often introduces a completely new set of activities, for example, direct part marking, tagging and “permanent” label. Moreover, these activities could affect the safety and effectiveness of the device and may necessitate a new premarket submission. On the other hand, the UDI rule provides for self-exception from the DM requirement if certain criteria are met.

Learn more about the DM requirement, the types of devices that it applies to, the exception criteria, and the different types of solutions available.
The discussion will include:
  • The Direct Mark (DM) requirement
  • DM exception criteria
  • Overview of solutions available
  • Live Q & A session
Who should attend?
  • UDI Team Leaders/Members
  • Regulatory Leaders/Teams
  • Manufacturing, Operations and Supply Chain Logistics
  • UDI IT Support
  • Distributors with UDI Submission Responsibilities
About the Presenters:
Jay Crowley

Vice President of Unique Device Identification Solutions Jay was Senior Advisor for Patient Safety in the Food and Drug Administration’s Center for Devices and Radiological Health. Jay developed the framework and authored key requirements for the FDA’s Unique Device Identification system.

Grant Hodgkins
Grant Hodgkins

Vice President of the ERP, PLM and Track & Trace Services and Solutions at USDM Life Sciences With over 30 years of experiences in the Life Sciences, Grant assists USDM Life Sciences clients with Pharmaceutical Track and Trace, Enterprise Resource Planning (ERP), Product Information Management (PIM), Product Lifecycle Management (PLM), Manufacturing Execution Systems (MES) and other commercial enterprise solutions.

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