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> Introduction to Medical Software

Introduction to Medical Software Foundations for Digital Health, Devices, and Diagnostics

Authors

Xenophon Papademetris, Yale University, Connecticut, Ayesha N. Quraishi, Harvard Medical School and Yale University, Connecticut, Gregory P. Licholai, Yale University, Connecticut
Published 2022

Description

Providing a concise and accessible overview of the design, implementation and management of medical software, this textbook will equip students with a solid understanding of critical considerations for both standalone medical software (software as a medical device/SaMD) and software that is integrated into hardware devices. It includes: practical discussion of key regulatory documents and industry standards, and how these translate into concrete considerations for medical software design; detailed coverage of the medical software lifecycle process ; accessible introduction to quality…

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Key features

  • Reviews key regulatory statements to ensure students understand the role of regulation in medical software development
  • Focuses on the enabling activities that support programmers in producing high-quality medical software, rather than specific programming scenarios
  • Cautionary case studies illustrate the consequences of poor design to students

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