Medical Device Software: Software Development LifeCycle Methodologies, Tools and Risk Management

Medical / General



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.

price: $77.00 more details

Download Now Read Online

Medical Device Software Verification Validation And Compliance


Download Now Read Online

Author by : David A. Vogel
Languange Used : en
Release Date : 2010
Publisher by : Artech House

HereOCOs the first book written specifically to help medical device and software engineers, QA and compliance

New Trends In Software Methodologies Tools And Techniques


Download Now Read Online

Author by : H. Fujita
Languange Used : en
Release Date : 2016-08-30
Publisher by : IOS Press

Software has become an essential enabler for science and the economy. Not only does it create new markets and

Robotics Concepts Methodologies Tools And Applications


Download Now Read Online

Author by : Management Association, Information Resources
Languange Used : en
Release Date : 2013-10-31
Publisher by : IGI Global

"This book explores some of the most recent developments in robotic motion, artificial intelligence, and human

The Medical Device Industry


Download Now Read Online

Author by : John Burton
Languange Used : en
Release Date : 2009-03-26
Publisher by : Cambridge Scholars Publishing

The Medical Device industry is one of the fastest growing industries in the world. Device manufacturers are pr

Human Computer Interaction Concepts Methodologies Tools And Applications


Download Now Read Online

Author by : Management Association, Information Resources
Languange Used : en
Release Date : 2015-10-02
Publisher by : IGI Global

As modern technologies continue to develop and evolve, the ability of users to interface with new systems beco

Making Globally Distributed Software Development A Success Story


Download Now Read Online

Author by : Qing Wang
Languange Used : en
Release Date : 2008-04-29
Publisher by : Springer Science & Business Media

This book constitutes the refereed proceedings of the Second International Conference on Software Process, hel

New Trends In Software Methodologies Tools And Techniques


Download Now Read Online

Author by : A. Selamat
Languange Used : en
Release Date : 2014-08-29
Publisher by : IOS Press

Software is the essential enabling means for science and the new economy. It helps us to create a more reliabl

Leave a Reply