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Medical device software development - a perspective from a lean manufacturing plant

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Show simple item record Cawley, Oisín Richardson, Ita Wang, Xiaofeng 2011-12-14T16:51:05Z 2011-12-14T16:51:05Z 2011
dc.description non-peer-reviewed en_US
dc.description.abstract Developing software for the manufacture of medical devices is a sensitive operation from many perspectives, such as: safety and regulatory compliance. Medical Device companies are required to have a well defined development process in place, which includes software development, and be able to demonstrate that they have followed it through the complete life-cycle of the device. With the increasing complexity of Medical Devices, and more detailed software development regulations among some of the influencing factors, we take a look at how some of these factors have impacted the software development process within a medical device manufacturing plant. We find that tying down your process across the board can have unwanted consequences. As process flexibility is required, we have investigated the usefulness of Lean Software Development en_US
dc.language.iso eng en_US
dc.relation.ispartofseries Software Process Improvement and capability determination (SPICE 2011);05/2011
dc.subject medical device en_US
dc.subject regulated environment en_US
dc.subject process improvement en_US
dc.subject lean software development en_US
dc.title Medical device software development - a perspective from a lean manufacturing plant en_US
dc.type Conference item en_US
dc.type.supercollection all_ul_research en_US
dc.type.supercollection ul_published_reviewed en_US
dc.type.restriction none en
dc.contributor.sponsor SFI
dc.contributor.sponsor IGERDF
dc.contributor.sponsor ISERC
dc.relation.projectid 07/SK/I1299
dc.relation.projectid 08/IN.1/I2030
dc.relation.projectid 03/CE2/I303_1

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