May 8-11, 2017 | David L. Lawrence Convention Center | Pittsburgh, Pennsylvania | Exhibits May 9-11

Regulatory & Quality System Considerations for 3D Printed Medical Devices


May 8, 2017 8:00 am - 1:00 pm

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WORKSHOP LEADER: Janelle Schrot, Materialise

INSTRUCTORS: Matthew DiPrima, Food & Drug Administration; Kim Torluemke, 3D Systems, Jenny Jones, Materialise; Beatrice Ogembo, American Preclinical Services; Gilbert Cortes, Johnson & Johnson

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 it applied to 3D printed devices. Discussion will include device classes, verification, validation, testing, PMA, IQ, OQ, PQ and more.

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
  • Learn the latest available information on regulatory clearance processes specific to 3D printing

Gilbert A. Cortes CQE, CQA, MBB

Quality Engineering Director
Johnson & Johnson

Gilbert A. Cortes is a Quality Engineering Director with Johnson & Johnson