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Additive Manufacturing (AM)

AM showcases the latest technology and industry developments with in-depth case studies, resources, interviews with experts and events.

    Kim Torluemke

    Kim Torluemke

    Medical Device Regulatory Professional
    KT Regulatory Consulting
    Kim Torluemke began her career in 3D printing by leading the development effort on one of the industry’s first FDA cleared 3d printed product in 2009. She continued on a path of increasing quality and regulatory oversight which, at its height, included oversight for 3D printed medical devices, dental products, and software as medical device produced across 5 sites on 3 continents. After ending her tenure with 3D Systems as their Vice President of Regulatory, she has started lending her expertise guiding clients through the evolving landscape of regulation to ensure safe and effective products make it efficiently to market.

    Kim holds a BS from the Colorado School of Mines in Mechanical Engineering, and received her Regulatory Affairs Professional RAC US in 2018.

    content by Kim Torluemke

    3D Printing for Aerospace – Quality Requirements

    3D printers have demonstrated capability of so much. There are many wow inducing, human race compelling, case studies in healthcare, construction, space, automotive, and aerospace. We are not talking about fidgets, prototypes, or paperweight models. We are talking about flight critical (safety-critical) parts. Honeywell, Boeing, and Lockheed Martin are all using 3D printing for critical […]

    Patient-Specific Devices Regulation and Questions

    Patient-specific devices are nearing standard of care in several areas and many hospitals are eager to take the near automated workflows being sold for general purposes by 3D Printing companies in-house to produce these perfectly matched parts more efficiently for their patients. Does this make the hospital institutions medical device manufacturers, or does the regulatory […]