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So, You Think You Have a 3D Printed Medical Device? A High-level Review of Regulatory & Quality System Considerations

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  • access_time - ET
  • location_onMcCormick Place
  • gamesWorkshop
  • monetization_onPaid Upgrade
  • schoolIntermediate

As the number of medical devices manufactured using additive manufacturing/3D printing technologies continues to increase, manufacturers struggle with the quality, validation, and filing processes to have each device cleared for use. This workshop brings together technology and process experts to walk participants through the considerations at every step as its applied to 3D printed devices. Discussion will include certification, validation, verification, testing, IP, clinical trials, and marketing considerations.

Learning Objectives:

  • Gain insight into FDA's view of 3D Printing as applied to medical devices
  • Obtain an overview of the types of 3D printed medical devices that have been cleared
  • Understand how quality, controls, validation and verification can be accomplished with 3D printing