Medical Device Software: Software Development LifeCycle Methodologies, Tools and Risk Management
$ 251
Availability: Currently in Stock
Delivery: 10-20 working days
Condition: USED (All books are in used condition)
Condition - Very Good The item shows wear from consistent use, but it remains in good condition and functions properly. Item may arrive with damaged packaging or be repackaged. It may be marked, have identifying markings on it, or have minor cosmetic damage. It may also be missing some parts/accessories or bundled items.
Medical Device Software: Software Development LifeCycle Methodologies, Tools and Risk Management
Medical devices today rely extensively on software for a wide variety of functions, but software integration brings unique challenges in safety-critical medical applications. To equip device manufacturers with software-focused product lifecycle framework, this study explores three areas: software development methodologies, risk management practices, and software development tools. The research identifies that the two most common software development methodologies currently used in the medical device industry are the traditional Waterfall, and the more recent Agile/Scrum method whose customizations are discussed for the regulated environment. Some of the risk management best practices include risk-based software development approach of IEC 62304, Human Factors Engineering (HFE) methods, assurance cases and FMEA tool. A software lifecycle framework is proposed by integrating risk management practices into the modified Agile/Scrum methodology. The tools for software development such as requirements, configuration, build, test and defect management, and those for Application Lifecycle Management (ALM), are explored to suggest ways in which to automate this framework.
