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> Introduction to Medical Software

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

Authors

, Yale University, Connecticut, , Harvard Medical School and Yale University, Connecticut, , 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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