Engineering High Quality Medical Software

Regulations, standards, methodologies and tools for certification

Inbunden, Engelska, 2018

2 139 kr

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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.

Produktinformation

Utgivningsdatum2018-03-29
Mått156 x 234 x 22 mm
Vikt588 g
FormatInbunden
SpråkEngelska
SerieHealthcare Technologies
Antal sidor296
FörlagInstitution of Engineering and Technology
ISBN9781785612480

Tillhör följande kategorier

Biomedicinsk teknik inom Medicin
Hälsoinformatik inom Medicin
Biovetenskap inom Naturvetenskap och teknik

Part I: IntroductionChapter 1: Introduction Part II: RegulationsChapter 2: EU MDD 93/42/EECChapter 3: FDA title 21 of US CFRChapter 4: Regulations for other markets Part III: StandardsChapter 5: ISO 13485: medical devices - quality management systems- requirements for regulatory purposesChapter 6: ISO 14971: medical devices - application of risk management to medical devicesChapter 7: IEC 52304: medical device software - software life-cycle processesChapter 8: IEEE 1012 and ISO/IEC 29119: standards for software verification Part IV: Verification and validation techniquesChapter 9: Static testingChapter 10: Dynamic testingChapter 11: Formal verification Part V: Techniques, methodologies, and engineering tasks for the development, configuration and maintenanceChapter 12: Prescriptive software development life cyclesChapter 13: Agile software development life cyclesChapter 14: Project managementChapter 15: Risk managementChapter 16: Requirements managementChapter 17: Design controls and development managementChapter 18: Test management and defect managementChapter 19: Change management, configuration management and change management Part VI: ConclusionsChapter 20: Conclusions