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Engineering High Quality Medical Software: Regulations, standards, methodologies and tools for certification

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Author(s): Antonio Coronato 1
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Publication Year: 2018

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.

Inspec keywords: medical computing; certification; standards; software quality

Other keywords: risk management; certification; quality management; project management; high quality medical software engineering; software as a medical device; standards

Subjects: Biology and medical computing; Software engineering techniques; General and management topics

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