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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 and risk management systems in the context of medical software; succinct coverage of essential topics in data science, machine learning, statistics, cybersecurity, software engineering and healthcare bring readers up-to-speed; six cautionary real-world case studies illustrate the dangers of improper or careless software processes. Accompanied by online resources for instructors, this is the ideal introduction for undergraduate students in biomedical engineering, electrical engineering and computer science, junior software engineers, and digital health entrepreneurs. Review: Good book!! - It is a good book to kindly deal with all important topics in medical S/W. The book includes all the real issues in the medical S/W industry such as S/W development, FDA, S/W life cycles, test and validations .... I strongly recommend this book to general CS students and S/W developers who want to expand their boundaries in the medical device industry. Review: I recommend it - Very well-written and structured. It covers regulations, quality controls, and risk with good examples.
| Best Sellers Rank | #904,401 in Books ( See Top 100 in Books ) #144 in Biomedical Engineering #274 in Family & General Practice (Books) #362 in Family Practice Medicine |
| Customer Reviews | 5.0 out of 5 stars 8 Reviews |
W**K
Good book!!
It is a good book to kindly deal with all important topics in medical S/W. The book includes all the real issues in the medical S/W industry such as S/W development, FDA, S/W life cycles, test and validations .... I strongly recommend this book to general CS students and S/W developers who want to expand their boundaries in the medical device industry.
A**S
I recommend it
Very well-written and structured. It covers regulations, quality controls, and risk with good examples.
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