Introduction to Medical Software

The goal of this book is to provide in one brief and accessible volume a survey of the critical material involved in the design, implementation, and management of medical software, especially for “Software as a Medical Device” (SaMD). One will find more detailed treatments of many of the topics covered in this book in specialized books that focus on some of the topics we cover (e.g., Software Engineering and Machine Learning). Our hope is to familiarize the reader with the span of topics he or she may need in entering this field and to provide pointers to more specialized publications as this becomes necessary. We also address the challenges created by the increasing use of big data and artificial intelligence/machine learning (AI/ML) techniques. We include a detailed description of an example project, the design of an image-guided neurosurgery application, to illustrate the core concepts in the book.

See also the official page at the webpage of Cambridge University Press and this blog post written by one of the authors.

The book is also available from Amazon. For more details see this page.


You can find additional information including the abstracts of all the chapters and the bibliography on this page.


This 12-week class presents an introduction to medical software and is a companion to the book above. The URL for the class is https://www.coursera.org/learn/introduction-to-medical-software.

A detailed table of contents can be found on this page. The class was recorded in July 2021 and was launched on the 12th of October, 2021.

This is a set of interviews with experts from industry, academia and government agencies on medical software and related topics. Excerpts from these interviews were used as part of the Coursera class. The complete interviews are available in this channel.

For more information see this page.

The full YouTube Channel can be found here.

  • Dr. Xenophon Papademetris is a Professor of Radiology & Biomedical Imaging, and Biomedical Engineering at Yale University.

  • Dr. Ayesha N. Quraishi is a Lecturer at the Yale School of Management, a Clinical Instructor, Harvard Medical School and Chief, Division of Otolaryngology, Cambridge Health Alliance.

  • Dr. Gregory P. Licholai is a Lecturer Yale School of Management and at Harvard Business School. He is the Chief Medical and Information Officer at ICON.


For more details see the instructors page.