Название: Engineering High Quality Medical Software: Regulations, Standards, Methodologies and Tools for Certification Автор: Antonio Coronato
Издательство: Institution of Engineering & Technology
Год: 2018
ISBN: 9781785612480
Серия: Healthcare Technologies (Book 12)
Формат: pdf
Страниц: 296
Размер: 30,2 mb
Язык: English
No longer confined to medical devices, medical software has become a pervasive technology giving healthcare operators access to clinical information stored in electronic health records and clinical decision support systems, supporting robot-assisted telesurgery, and providing the technology behind ambient assisted living. These systems and software must be designed, built and maintained according to strict regulations and standards to ensure that they are safe, reliable and secure.
Engineering High Quality Medical Software illustrates how to exploit techniques, methodologies, development processes and existing standards to realize high-confidence medical software. After an introductory survey of the topic the book covers global regulations and standards (including EU MDD 93/42/EEC, FDA Title 21 of US CFR, ISO 13485, ISO 14971, IEC 52304, IEEE 1012 and ISO/IEC 29119), verification and validation techniques and techniques, and methodologies and engineering tasks for the development, configuration and maintenance of medical software.