John Schalago

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Novartis
Executive Director of Regulatory Affairs Innovation
John Schalago is Executive Director of Regulatory Affairs Innovation at Novartis focused on digital innovation. He is a regulatory/quality/clinical professional with over 25 years of experience in research and development, quality assurance and control, clinical affairs, regulatory affairs, and executive management. John started his career as an analytical chemist before moving into regulatory affairs, where his responsibilities have included managing FDA interactions and submissions to CBRH, CBER, and CDER. He has an undergraduate degree in chemistry and a masters in biochemical engineering, as well as certifications in regulatory affairs, healthcare compliance, and drug development.

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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.