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

ISBN-13: 9781316514993 / Angielski / Twarda / 2022

Xenophon Papademetris; Ayesha N. Quraishi; Gregory P. Licholai

Opis

A concise and accessible overview of the design, implementation and management of medical software.

Spis treści

Preface; Part 1. Regulatory, Business and Management Background: 1. Introduction to medical software; 2. The FDA and software; 3. Operating within a healthcare system; 4. Quality management systems; 5. Risk management; 6. Taking an idea to market: understanding the product journey; 7. Medical software applications and growth drivers; Part II. Scientific and Technical Background: 8. Mathematical background; 9. Topics in software engineering; Part III. An Example Medical Software Life Cycle Process: 10. The overall process; 11. Identifying user needs; 12. The system requirements specification; 13. The software design document; 14. Software construction and testing and verification; 15. Software validation; 16. Deployment, maintenance and decommissioning; Part IV. Case Studies: 17. Therac-25: software that killed; 18. Mars Climate Orbiter: lost without a trace; 19. Healthcare.gov: the failed launch of a critical webpage; 20. The 2020 Iowa Caucus app: an unreliable app that caused national embarrassment; 21. The Boeing 737-MAX disasters: using software to fix hardware problems; 22. The averted Y2K crisis: successful crisis and risk management; References; Index.