Whitney Hartung

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Novartis
Materials Scientist & Engineer
Whitney Hartung, Dr sc, is a materials scientist and engineer with a BS from Case Western Reserve University in Cleveland, Ohio, a MS from Christian-Albrechts-Universität in Kiel, Germany, and a Dr sc from ETH Zürich, Switzerland. She has worked in the medical device industry since 2009 in a variety of roles, including quality assurance, manufacturing process development, device and materials characterization, and project management, and has worked on various medical devices, including orthopedic implants and drug-coated cardiac stents. Whitney has been working at Novartis since 2017 as a Medical Device Project Leader for inhalers, connected devices, decision support software, and autoinjectors. She was also part of the team that achievedthe first EC Certificate under the new EU Medical Device Regulation (MDR).

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Figure 1: Software in healthcare.
Technical
Software as a Medical Device Fundamentals

Software as a medical device (SaMD) is software intended to be used for one or more medical purposes without being part of a medical device.1

  • 1International Medical Device Regulators Forum. “Software as a Medical Device (SaMD): Key Definitions.” 9 December 2013.