Thumbnail Image
Publication

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

Date
2011
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
Supervisor
Description
non-peer-reviewed
Publisher
Citation
Software Process Improvement and capability determination (SPICE 2011);05/2011
Collections
Lero - The Science Foundation Ireland Research Centre for Software
Show all metadata
Files
Thumbnail Image
2011_Cawley.pdf
Adobe PDF, 371.52 KB
Keywords
medical device, regulated environment, process improvement, lean software development
ULRR Identifiers
https://hdl.handle.net/10344/1703
 https://doi.org/10.34961/9632
Funding code
Funding Information
Science Foundation Ireland (SFI), IGEuropean Regional Development Fund (ERDF), ISERC
Sustainable Development Goals
External Link
Type
Meetings and Proceedings
Rights
https://creativecommons.org/licenses/by-nc-sa/1.0/
License