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SOFTWARE RISK MANAGEMENT: AN EXPLORATION OF SOFTWARE LIFE
CYCLE METHODOLOGIES, BEST PRACTICES AND TOOLS FOR THEIR
APPLICATION TO MEDICAL DEVICE SOFTWARE RISK MANAGEMENT
by
Taranjit Singh Samra
________________________________________________________________
A Dissertation Presented to the
FACULTY OF THE USC SCHOOL OF PHARMACY
UNIVERSITY OF SOUTHERN CALIFORNIA
In Partial Fulfillment of the
Requirements for the Degree
DOCTOR OF REGULATORY SCIENCE
May 2012
Copyright 2012 Taranjit Singh Samra
Object Description
| Title | Software risk management: an exploration of software life cycle methodologies, best practices and tools for their application to medical device software risk management |
| Author | Samra, Taranjit Singh |
| Author email | taranjis@usc.edu;taranjitmail@yahoo.com |
| Degree | Doctor of Regulatory Science |
| Document type | Dissertation |
| Degree program | Regulatory Science |
| School | School of Pharmacy |
| Date defended/completed | 2012-01-13 |
| Date submitted | 2012-03-16 |
| Date approved | 2012-03-17 |
| Restricted until | 2012-03-17 |
| Date published | 2012-03-17 |
| Advisor (committee chair) | Loeb, Gerald |
| Advisor (committee member) |
Kaplan, Hilton Davies, Daryl Richmond, Francis |
| Abstract | Medical devices today rely extensively on software for a wide variety of functions. Device manufacturers must be equipped with software-focused risk management approaches, because software integration brings unique challenges in safety-critical medical applications. This study explores various approaches to foster the development of a software risk management (SRM) model throughout the software lifecycle (SLC). A combination of interviews and other exploratory methods including the inspection of documents and other artifacts were carried out to characterize activities in three areas: software development methodologies; risk management best practices throughout SLC, and software development and lifecycle management tools. The research identified that the two most common software development methodologies used in the medical device industry today are the traditional Waterfall and the more recent Agile method, whose customizations are discussed. Best practices identified as important for risk activities included the use of IEC-62304 standard for risk-based software development, Human Factors Engineering (HFE) methods, assurance cases and FMEA tool. With this knowledge, a SRM framework was developed in which certain risk management practices were implemented into the modified Agile/Scrum software development methodology. Then, tools for software development such as requirements, configuration, build, test and defect management, and those for Application Lifecycle Management (ALM), were explored to suggest ways in which to automate the SRM framework. |
| Keyword | agile; lifecycle; life cycle; medical device; risk management; software risk management; software; tools; product life cycle; product lifecycle; software development life cycle; software development lifecycle; software lifecycle; software life cycle; software development methodology; software development process; waterfall; design controls; FDA; regulated industry; ALM; application lifecycle management; IEC 62304; medical device software; software development tools; SLC; SDLC; SRM |
| Language | English |
| Part of collection | University of Southern California dissertations and theses |
| Publisher (of the original version) | University of Southern California |
| Place of publication (of the original version) | Los Angeles, California |
| Publisher (of the digital version) | University of Southern California. Libraries |
| Provenance | Electronically uploaded by the author |
| Type | texts |
| Legacy record ID | usctheses-m |
| Rights | Samra, Taranjit Singh |
| Access conditions | The author retains rights to his/her dissertation, thesis or other graduate work according to U.S. copyright law. Electronic access is being provided by the USC Libraries in agreement with the author, as the original true and official version of the work, but does not grant the reader permission to use the work if the desired use is covered by copyright. It is the author, as rights holder, who must provide use permission if such use is covered by copyright. The original signature page accompanying the original submission of the work to the USC Libraries is retained by the USC Libraries and a copy of it may be obtained by authorized requesters contacting the repository e-mail address given. |
| Repository name | University of Southern California Digital Library |
| Repository address | USC Digital Library, University of Southern California, University Park Campus MC 7002, 106 University Village, Los Angeles, California 90089-7002, USA |
| Repository email | cisadmin@usc.edu |
| Archival file | uscthesesreloadpub_Volume6/etd-SamraTaran-507.pdf |
Description
| Title | Page 1 |
| Full text | SOFTWARE RISK MANAGEMENT: AN EXPLORATION OF SOFTWARE LIFE CYCLE METHODOLOGIES, BEST PRACTICES AND TOOLS FOR THEIR APPLICATION TO MEDICAL DEVICE SOFTWARE RISK MANAGEMENT by Taranjit Singh Samra ________________________________________________________________ A Dissertation Presented to the FACULTY OF THE USC SCHOOL OF PHARMACY UNIVERSITY OF SOUTHERN CALIFORNIA In Partial Fulfillment of the Requirements for the Degree DOCTOR OF REGULATORY SCIENCE May 2012 Copyright 2012 Taranjit Singh Samra |
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